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Insight & Intelligence™ : May 19, 2014

Biosimilars: 11 Drugs to Watch

If imitation is the sincerest form of flattery, these innovator drugs should be blushing.

May 9 saw the latest estimate of the potential size of the market for biosimilar drugs—$167 billion by 2017, according to Companiesandmarkets.com. It’s an exponential leap from the estimate made earlier this year by Frost & Sullivan that biosimilar sales will reach $23 billion in 2019, up from what it estimated as $1.2 billion in 2013 sales.

The past few years has seen a flurry of worldwide activity by drug developers in creating, winning regulatory approvals for, then launching biosimilars. The operative word here is “worldwide”—Europe remains miles ahead of the U.S. The European Medicines Agency authorizes 18 biosimilar drugs for market in the nations comprising the EU. Meanwhile in the U.S., the FDA continues to ponder draft guidances for how the agency will evaluate biosimilars.

FDA insists it is moving ahead with careful review of new regulations. FDA’s Center for Drug Evaluation and Research (CDER) earlier this year published an agenda for new and revised draft guidances that included several new topics the agency said will be addressed: clinical pharmacology data to support a demonstration of biosimilarity to a reference product; considerations in demonstrating interchangeability to a reference product; labeling for biosimilar biological products; and reference product exclusivity for biological products. CDER also included a biosimilar topic published in previous agendas, additional questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009.

One reflection of increased activity: This year’s list reports on 11 biosimilars to watch, as Avastin (bevacizumab) and Erbitux (cetuximab) have been added to reflect an uptick in announcements or disclosures about biosimilar versions of those drugs since 2013, while Genotropin (somatropin or somatotropin) has been removed for not generating as much activity.

Following is a list of 11 drugs for which, over the past year, biosimilars have been launched to market somewhere in the world, were in clinical development, or whose development was ended. Drugs are listed by original brand name (generic name), followed by a list of drug developers with a brief summary of the status of their biosimilar, and its name where known; the nature of the drug and its indication; its 2013 sales (and the original drug’s maker or makers); and the drug’s patent status in the U.S. and EU.

Aranesp (darbepoetin alfa)

Drug developers:

  • Avesthagen Pharma (APAG): The spinout of Avesthagen said November 19, 2013, that it signed a distribution agreement  granting Greek-based Elpen Pharmaceutical rights to distribute APAG’s biosimilar darbepoetin alfa (Avdesp) in seven European Union countries (Bulgaria, Croatia, Cyprus, Greece, Romania, Slovakia, and Slovenia) and six non-EU territories (Albania, Bosnia, Former Yugoslav Republic of Macedonia, Kosovo, Montenegro, and Serbia). Avdesp is one of eight biosimilars marketed by APAG.
  • Dr. Reddy’s Laboratories: Cresp launched 2010 in India as that country’s only darbopoetin alfa of any kind, and as the world’s first generic darbopoetin alfa
  • Hospira: Retacrit marketed in EU, where it was authorized in December2007 for anemia associated with chronic renal failure or other kidney problems, adults receiving chemotherapy for some cancers. Also indicated to increase the amount of blood patients with moderate anemia can self-donate before surgery, and to reduce the need for blood transfusions in patients with moderate anemia about to undergo major bone surgery. In U.S., Phase III trial launched last year.
  • Merck: MK-2578 development halted in 2010
  • Stada: Silapo marketed in EU, where it was authorized December 2007 for anemia that is causing symptoms in patients with chronic renal failure; anemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions; and to increase the amount of blood patients with moderate anemia can self-donate before surgery.

Nature and indication: Erythropoiesis-stimulating agent (ESA) for anemia due to chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis; the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.

2013 sales: $1.911 billion, down 6% from 2012 (Amgen)

Patent status: Patent set to expire 2016 in EU; 2024 in U.S.

Avastin (bevacizumab)

Drug developers:

  • Amgen: Biosimilar in development, with pivotal trial launched in 2013, the company stated in a letter to shareholders accompanying its Form 10-K for last year. The biosimilar is one of four for oncology indications that Amgen is developing in collaboration with Actavis.
  • Biocad: Biosimilar in late-stage clinical study
  • BioXpress Therapeutics: Biosimilar in pipeline
  • Fujifilm and Kyowa Hakko Kirin: Announced a 50–50 joint venture, Fujifilm Kyowa Kirin Biologics, on October 24, 2012, to develop a biosimilar version of Avastin (Roche / Genentech) for cancer indications
  • Oncobiologics and Viropro: Biosimilar in development; one of six monoclonal antibody biosimilars on which the companies agreed to collaborate under an agreement announced February 25, 2013. Viropro has rights to manufacture the six products being developed by Oncobiologics, with Viropro holding exclusive commercialization rights to the six for Malaysia, while both companies will co-manage Viropro’s Penang, Malaysia Alpha Biologics biomanufacturing subsidiary.

Nature and indication: Vascular endothelial growth factor-specific angiogenesis inhibitor indicated for the treatment of: Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment; Metastatic colorectal cancer, with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen; Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease; Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy; Metastatic renal cell carcinoma with interferon alfa

2013 sales: $7.106 billion (CHF 6.254 billion) (Roche), up 8.5% from 2012

Patent status: Patent set to expire 2018 in Europe; 2019 in U.S.

Enbrel (etanercept)

Drug developers:

  • Avesthagen: Avent in preclinical studies as of 2012; received patent in India, 2010
  • BioXpress Therapeutics: Biosimilar in pipeline
  • Cipla: Marketed in India following launch last year as that country’s first etanercept biosimilar
  • CP Guojian Pharmaceutical: Markets biosimilar as Yisaipu in China and Etanar in Colombia
  • Hanwha Chemical: HD203 marketed in South Korea following approval in 2013.1
  • LG Life Sciences: LBEC0101 completed two Phase I studies, both comparison of safety and pharmacokinetics to Enbrel; one was completed as of 2013 (NCT01725620); the other, as of 2011 (NCT01145950).
  • Momenta: M923, company’s lead biosimilar program, predicted to be a near-copy of either Enbrel or Humira;2 company has not confirmed which, but has said it plans a regulatory filing later this year2
  • Mycenax Biotech: TuNEX in Phase III clinical trials in Japan and South Korea; completed a Phase I trial among 24 healthy subjects in South Korea, and a Phase I/II trial that enrolled 18 patients with rheumatoid arthritis in Taiwan
  • Protalix Biotherapeutics: PRX-106 in preclinical studies
  • Shanghai CP Goujian Pharmaceutical: Yisaipu, marketed in China; Etanar, marketed in Colombia

Nature and indication: Tumor necrosis factor (TNF) blocker for rheumatoid arthritis, polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged two years or older; psoriatic arthritis; ankylosing spondylitis; and plaque psoriasis

2013 sales: $8.760 billion (including $4.551 billion Amgen + $3.774 billion Pfizer + $0.435 billion Takeda)3

Patent status: Patents set to expire February 2015 in EU; U.S. patents set to expire 2028 and 2029

Epogen / Procrit / Eprex / Erypo (epoetin alfa)

Drug developers:

  • Biocon: Erypro Safe pre-filled syringes marketed in India following 2008 launch
  • Claris Lifesciences: Epotin marketed in India
  • Emcure: Epofer marketed in India
  • Hexal: Epoetin alfa Hexal marketed in EU, where it was authorized August 2007 for anemia, cancer and chronic kidney failure
  • Intas Biopharmaceuticals: Epofit/Erykine marketed in India, where it was launched 2005
  • Medice: Abseamed marketed in EU, where it was authorized August 2007 for anemia, cancer, and chronic kidney failure
  • Ranbaxy: Ceriton marketed in India
  • Reliance Life Sciences: Relipoietin marketed in India, where it was launched 2008
  • Sandoz: Binocrit marketed in EU, where it was authorized August 2007 for anemia and chronic kidney. In U.S., the company said October 25, 2012, that it has started patient enrolment in a Phase III clinical trial, comparing safety and efficacy of biosimilar with reference product Epogen/Procrit in anemia associated with chronic kidney disease.
  • Wockhardt: Wepox marketed in India, where it was launched 2001

Nature and indication: Erythropoiesis-stimulating agent for anemia due to chronic kidney disease in patients on dialysis and not on dialysis; due to Zidovudine in HIV-infected patients; and due to effects of concomitant myelosuppressive chemotherapy, where upon initiation, there is a minimum of two additional months of planned chemotherapy. Also, for reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery

2013 sales: $3.317 billion (including $1.953 billion for Epogen [Amgen], and $1.364 million combined for Procrit / Eprex [Johnson & Johnson], down 2.5% from 2012

Patent status: Patent set to expire 2015 in U.S.; expired 2004 in EU

Erbitux (cetuximab)

Drug developers:

  • Amgen: Developing a biosimilar in collaboration with Actavis
  • BioXpress Therapeutics: Biosimilar in pipeline
  • Oncobiologics and Viropro: Biosimilar in development; one of six monoclonal antibody biosimilars on which the companies agreed to collaborate under an agreement announced February 25, 2013. Viropro has rights to manufacture the six products being developed by Oncobiologics, with Viropro holding exclusive commercialization rights to the six for Malaysia, while both companies will co-manage Viropro’s Penang, Malaysia Alpha Biologics biomanufacturing subsidiary.

Nature and indication: Epidermal growth factor receptor (EGFR) antagonist indicated for locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy; recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU; recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy; KRAS mutation-negative (wild-type), EGFR-expressing, metastatic colorectal cancer in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, or as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan

2013 sales: $2.283 billion ($1.222 billion [€882 million] Merck KGaA + $696 million Bristol-Myers Squibb [BMS] + $373.7 million Eli Lilly [ImClone subsidiary]), down 1.7% from 2012

Patent status: Patent set to expire in Europe June 29, 2014; data exclusivity ends 2016 in U.S. As a biologic there is no patent that specifically claims the composition of matter of cetuximab. 

Herceptin (trastuzumab)

Drug developers:

  • Amgen: Biosimilar in development, with pivotal trial launched in 2013, the company stated in a letter to shareholders accompanying its Form 10-K for last year. The biosimilar is one of four for oncology indications that Amgen is developing in collaboration with Actavis.
  • Biocad: Biosimilar in late-stage clinical study
  • Biocon-Mylan: CanMab marketed in India; launched October 23, 2013, after Roche ended patent litigation against the companies
  • BioXpress Therapeutics: Biosimilar in pipeline
  • Celltrion: Herzuma set for launch in South Korea following approval by authorities
  • Hanwha Chemical: HD201 in Phase I study in Europe as of 2013. Hanwha has said it is seeking a partner to commercialize HD201 and HD203, a biosimilar for Enbrel
  • Hospira: Biosimilar, under license from Celltrion, expected to be submitted for marketing approval to European Medicines Agency later this year, following April 10 court decision by Justice Colin Birss invalidating patents related to the composition and dosages of trastuzumab
  • Oncobiologics and Viropro: Biosimilar in development; one of six monoclonal antibody biosimilars on which the companies agreed to collaborate under an agreement announced February 25, 2013. Viropro has rights to manufacture the six products being developed by Oncobiologics, with Viropro holding exclusive commercialization rights to the six for Malaysia, while both companies will co-manage Viropro’s Penang, Malaysia Alpha Biologics biomanufacturing subsidiary.
  • Pfizer: PF-05280014 in Phase III development for metastatic breast cancer, the company confirmed in its May 8, 2014, pipeline update. Seven days earlier, the company disclosed on ClinicalTrials.gov that it was recruiting patients for the study, named REFLECTIONS B327-02 and designed to assess the biosimilar plus Paclitaxel in HER2 positive first line metastatic breast cancer treatment (NCT01989676).
  • PlantForm: Clinical trials in humans expected to begin in 2014. Biosimilar expected to be launched, “in partnership with a pharmaceutical company,” in world markets in 2016
  • Stada Arzneimittel: Joined with Gedeon Richter in announcing plans August 2011 to collaborate on biosimilars for trastuzumab and rituximab. Richter agreed to buy from Stada trastuzumab for a “low single-digit million Euros figure,” they announce.

Nature and indication: Monoclonal antibody; erbB2 TK Inhibitor; human epidural receptor 2 (neu) receptor antagonist for aggressive HER positive metastatic and adjuvant breast cancer, for aggressive HER positive metastatic stomach or gastroesophageal junction cancer.

2013 sales: $6.908 billion (CHF 6.079 billion) (Roche), up 3.2% from 2012

Patent status: Patents set to expire July 28, 2014, in Europe, and 2019 in the U.S.

Humira (adalimumab)

Drug developers:

  • AET BioTech and BioXpress: Biosimilar being co-developed under agreement announced October 25, 2012; companies will be jointly responsible for development, registration, and manufacture of the biosimilar, based on BioXpress technology. AET BioTech will provide further investment in the biosimilar based on committed long-term financing, and oversee any future commercialization of the product.
  • Amgen: Biosimilar in development, company stated in its Form 10-K for 2013
  • BioXpress Therapeutics: Biosimilar in pipeline; development partnership announced October 25, 2012, with AET BioTech, the separate biosimilars business within the generic drug developer AET (Alfred E Tiefenbacher) Group, under which AET BioTech and BioXpress said they will be jointly responsible for the development, registration, and manufacture of the biosimilar
  • Boehringer Ingelheim: BI695501 is the subject of a Phase I clinical study (NCT02045979) assessing the biosimilar’s safety and pharmacokinetics compared to Humira (adalimumab); the study is ongoing but not recruiting participants, the company disclosed April 30 on ClinicalTrials.gov. A similar study was completed in New Zealand last year.
  • Fujifilm and Kyowa Hakko Kirin: Companies announced a 50–50 joint venture, Fujifilm Kyowa Kirin Biologics, to develop a biosimilar version of Adalimumab for rheumatoid arthritis. The venture is proceeding with preparations to begin clinical trials in Europe in the first half of 2013, the companies said October 24, 2012.
  • Momenta: M923 predicted to be a biosimilar for either Humira or Enbrel;4 company has not confirmed which, but has said it plans a regulatory filing later this year. M923 is company’s lead biosimilar program.
  • Oncobiologics and Viropro: Biosimilar in development; one of six monoclonal antibody biosimilars on which the companies agreed to collaborate under an agreement announced February 25, 2013. Viropro has rights to manufacture the six products being developed by Oncobiologics, with Viropro holding exclusive commercialization rights to the six for Malaysia, while both companies will co-manage Viropro’s Penang, Malaysia Alpha Biologics biomanufacturing subsidiary.

Nature and indication: Anti-TNF-α monoclonal antibody for moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, moderate to severe Crohn’s disease; moderate to severe ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, moderate to severe polyarticular juvenile idiopathic arthritis

2013 sales: $10.659 billion (AbbVie)

Patent status: Patent set to expire 2016 in U.S.; 2018 in EU

Neulasta (pegfilgrastim)

Drug developers:

  • Merck & Co.: MK-6302 said to be in clinical development as of 2011 for neutropenia caused by cancer chemotherapy; no further announcement since then on ‘6302, acquired through acquisition of Insmed in 2009
  • Sandoz: Two Phase III studies completed last year: PROTECT1, which compared the efficacy and safety of branded Neulasta with LA-EP2006 (NCT01735175); and PROTECT2, which compared the efficacy and safety of the biosimilar to LA-EP2006 (NCT01516736). Both studies measured the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
  • Teva: Company withdrew application for Balugrastim (formerly Neugranin) in November 2013, citing ongoing consultation with the FDA. Launch delayed in 2011, when company reached settlement of litigation with Amgen in which it agreed not to sell Neugranin until November 2013 unless it first obtained a final court decision that Amgen patents were not infringed by the biosimilar.

Nature and indication: Leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia

2013 sales: $4.392 billion (Amgen), up 7% from 2012

Patent status: Patents set to expire August 2015 in EU; October 2015 in U.S.

Neupogen (filgrastim)

Drug developers:

  • Apotex: Grastofil marketed in EU, where it was authorized October 18, 2013, for neutropenia
  • Biocon and Celgene: Nufil marketed in India by Biocon; in active development for EU by joint venture
  • ctArzneimittel: Biograstim marketed in EU, where it was authorized September 2008 for cancer, hematopoietic stem cell transplantation, and neutropenia
  • Dr. Reddy’s Laboratories: Grafeel marketed in India
  • Hexal: Filgrastim Hexal marketed in EU, where it was authorized February 2009 for cancer, hematopoietic stem cell transplantation, and neutropenia
  • Hospira: Nivestim marketed in EU, where it was authorized June 2010 for cancer, hematopoietic stem cell transplantation, and neutropenia
  • Intas/Apotex: Neukine in Phase III development
  • Merck & Co.: MK-4214 in Phase III clinical development as of 2012; acquired through acquisition of Insmed in 2009
  • Ratiopharm: Ratiograstim marketed in EU, where it was authorized September 2009 for cancer, hematopoietic stem cell transplantation, and neutropenia. Authorization withdrawn voluntarily March 2011, followed two months later by formal European Commission withdrawal.
  • Sandoz: Zarzio marketed in EU, where it was authorized February 2009 for cancer, hematopoietic stem cell transplantation, and neutropenia In U.S., recruiting patients as of January 2013 for a noninterventional, long-term safety data collection of the biosimilar and Filgrastim Hexal in stem cell donors, according to ClinicalTrials.gov (NCT01766934)
  • Stada Arzneimittel: Grastofil, inlicensed from Apotex, set for a 2014 launch after winning approval in October 2013 from the European Commission for the treatment of neutropenia in adults
  • Teva: Tevagrastim marketed in EU, where it was authorized September 2008 for cancer, hematopoietic stem cell transplantation, and neutropenia

Nature and indication: Granulocyte colony-stimulating factor (G-CSF) for neutropenia caused by the drugs used to treat cancer

2013 sales: $1.398 billion, up 11% from 2012 (Amgen)5

Patent status: Patent expired December 2013 in U.S.; Patent expired 2006 in EU

Remicade (infliximab)

Drug developers:

  • Amgen: Biosimilar in active development, company stated in its Form 10-K for 2013
  • BioXpress Therapeutics: Biosimilar in pipeline
  • Celltrion: Ramsima (formerly CT-P13) marketed in South Korea, having won approval in July 2012 as the first Remicade biosimilar to be approved in the world. Indicated for rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, and psoriasis. Applied for marketing authorization in EU.
  • Hospira: Inflectra marketed in EU and other markets, including the U.S., under license from Celltrion for rheumatoid arthritis (RA), ankylosing spondylitis (AS), Crohn's disease, ulcerative colitis psoriatic arthritis and psoriasis; European launch followed approval September 2013 by the European Commission. First monoclonal antibody to be approved through the European Medicines Agency’s biosimilars regulatory pathway.
  • Ranbaxy Laboratories and Epirus Biopharmaceuticals: BOW015 to be developed and supplied by Epirus under license agreement with Ranbaxy, which upon regulatory approval will market the product in India and other unnamed “emerging markets,” the companies announced January 9, 2014

Nature and indication: Tumor necrosis factor (TNF) blocker for moderately- to severely-active rheumatoid arthritis in adults, in combination with methotrexate; Crohn's Disease in children 6 years and older, and adults who have not responded well to other medicines; rheumatoid arthritis; ankylosing spondylitis; psoriatic arthritis; chronic, severe, extensive, and/or disabling plaque psoriasis in adults; moderately to severely active ulcerative colitis in children 6 years and older and adults that have not responded well to other medicines.

2013 sales: $8.944 billion ($6.673 billion Johnson & Johnson + $2.271 billion Merck & Co.), up 8.9% from 2012

Patent status: Patents set to expire February 2015 in Europe, and 2018 in U.S.

Rituxan / MabThera (rituximab)

Drug developers:

  • Amgen: Biosimilar in development, with pivotal trial launched in 2013, the company stated in a letter to shareholders accompanying its Form 10-K for last year. The biosimilar is one of four for oncology indications that Amgen is developing in collaboration with Actavis.
  • Biocad: AcellBia registered in Russia; first monoclonal antibody biosimilar to receive a positive opinion from regulators. Agreement signed last year for export of rituximab APIs produced by Biocad and Kocak Farma
  • BioXpress Therapeutics: Biosimilar in pipeline
  • Boehringer Ingelheim: BI695500 in three trials recruiting patients as of April 30, according to ClinicalTrials.gov: A Phase III study assessing efficacy, pharmacokinetics, and safety of the biosimilar in patients with rheumatoid arthritis (NCT01682512); a Phase III study assessing the safety and efficacy of the biosimilar in patients with moderately to severely active rheumatoid arthritis (NCT01955733); and a Phase I study assessing the pharmacokinetics and pharmacodynamics of BI 695500 vs. rituximab as first-line treatment in patients with low-tumor-burden lymphoma (NCT01950273)
  • Celltrion and Hospira: Conducting Phase I trial in South Korea of CT-P10 for RA and another Phase I trial for lymphoma.
  • Dr. Reddy’s Laboratory: Reditux marketed in Bolivia, Chile, India, and Peru
  • iBio: Biosimilar in Phase I development. Company says its iBioLaunch platform, a gene expression technology that causes nontransgenic plants to rapidly produce high levels of target proteins, addresses several multibillion dollar markets including “biosimilars/bio-betters.” Announced October 5, 2011 that it produces rituximab in nontransgenic green plants.
  • Intas Biopharmaceuticals: MabTas marketed in India following launch February 26, 2013
  • Merck: MK-8808 the subject of U.S. clinical trials NCT01390441 and NCT01370694, both of which are active but not recruiting as of April 16 and May 1, respectively, the company disclosed on ClinicalTrials.gov
  • Oncobiologics and Viropro: Biosimilar in development; one of six monoclonal antibody biosimilars on which the companies agreed to collaborate under an agreement announced February 25, 2013. Viropro has rights to manufacture the six products being developed by Oncobiologics, with Viropro holding exclusive commercialization rights to the six for Malaysia, while both companies will co-manage Viropro’s Penang, Malaysia Alpha Biologics biomanufacturing subsidiary.
  • Pfizer: PF-05280586 in Phase I development for rheumatoid arthritis, the company confirmed in its May 8, 2014, pipeline update. Two trials ongoing but not recruiting participants, REFLECTIONS B327-01, a Phase I/II pharmacokinetic/pharmacodynamic study which compares the biosimilar to rituxumab in subjects with active rheumatoid arthritis with an inadequate response To TNF inhibitors (NCT01526057); and -06, an extension trial for patients who have participated in other PF-05280586 trials (NCT01643928)
  • Probiomed: Kikuzubam marketed in Bolivia, Chile, Mexico, and Peru
  • Roche: CEO Severin Schwan was quoted in March 2013 as pushing back his company’s anticipated launch of a rituximab biosimilar beyond the 2016 date he had earlier cited in The Wall Street Journal, until the end of this decade.
  • Samsung Biologics: Venture between Samsung and Quintiles halts development of SAIT101, in October 2012, reportedly due to uncertainty over biosimilar regulation in the U.S.
  • Sandoz: GP2013 in two clinical trials now recruiting patients: Phase III ASSIST_FL study assessing biosimilar in treatment of patients with previously untreated Advanced Stage Follicular Lymphoma (NCT01419665), the company told ClinicalTrials.gov on April 10, 2014; and a Phase I study in Japanese patients with CD20-positive low tumor burden indolent B-cell non-Hodgkin’s lymphoma (NCT01933516), according to the trial’s most recent update on August 28, 2013 
  • Stada Arzneimittel: Joined with Gedeon Richter in announcing plans August 2011 to collaborate on biosimilars for rituximab and trastuzumab. Stada receives nonexclusive rights to sell Richter-produced rituximab in Europe and the Commonwealth of Independent States, excluding Russia. In addition to an undisclosed payment to Richter, Stada also agrees to pay Richter based on progress of the development of rituximab to a “low double-digit million Euros”
  • Teva and Lonza: On July 25, 2013, announce they will end four-year-old joint venture to develop, manufacture, and market biosimilar drugs, more than three months after Lonza issues a statement denying it will end the joint venture in response to its CEO, Richard Ridinger, telling the Swiss newspaper Finanz und Wirtschaft it was reviewing whether to continue the effort.
  • Zenotech Laboratories: Biosimilar marketed in India following launch February 27, 2013

Nature and indication: Chimeric mouse-human monoclonal antibody, for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis

2013 sales: $8.998 billion [$7.898 billion (CHF 6.951 billion) Roche + $1.1 billion Biogen Idec], up 3.2% from 20126

Patent status: Patents expired November 2013 in EU, and set to expire 2018 in U.S.