The Case Against Biosimilars
Delegates and speakers at “BioSquare” differed in their opinions about the increase in numbers of biosimilars and how it would affect the global pharma market. According to Thomas Bols, director of government affairs, Europe, at Amgen (www.amgen.com), “Biosimilars will play a limited role in patient care because in many cases newer innovative biotechnology medicines are available that offer advantages. Also biosimilar companies may not have the ability to develop and manufacture complex biological molecules.”
Dr. Morawala-Patell agreed, “Scale-up of protein therapeutics is not easy and even major Indian pharmas like Ranbaxy (www.ranbaxy.com) are manufacturing bacterial-based proteins and only Avesthagen and Biocon (www.biocon.com) are using mammalian cell culture.”
“Biosimilars will be copies of older biological products, and since their introduction, in many cases, newer biotechnology medicines are available that offer benefits over the ones that biosimilars attempt to imitate,” Bols reiterated. “We believe patients and medical professionals have the right to access the most appropriate medicines and should not be forced to use biosimilars based purely on economic grounds as newer innovations may offer better care. Also biosimilars may not even offer the same price discounts as generics due to the complexity and costs of manufacturing.”
The main strategies suggested to combat the rise in biosimilars were: bolstering pipelines with new innovations; adding new technologies to decrease manufacturing costs; and providing more effective or palatable drug delivery.
“The way to protect against generic competition is to continually innovate, and we have done this by taking on board technologies for our portfolio of drugs through such activities as our acquisition of Glycart and partnership with Halozyme,” explained Nigel Sheail, global head of licensing pharma partnering at Roche (www.roche.com). “The technology from Glycart has the potential to improve the efficacy of antibodies and increase production yields. At the other end of the chain, Halozyme’s technology may allow for subcutaneous delivery of biologics currently administered by infusion.”
At “BioSquare”, there was no shortage of biotech companies with novel ideas, all of which were up for grabs to discerning pharma partners. For example, Kiadis Pharma (www.kiadis.com) presented a method of activating drug toxicity using light. “We use a platform known as Theralux™, which is based upon a photosensitive compound (TH9402) that can be selectively retained in actively growing cells such as cancer cells and activated T cells,” Maarten Frijlink, director of business development, noted.
“On exposure to light, cells that retain the drug die, leaving other cells unharmed.” Kiadis has used its Theralux technology to create drug candidates. Kiadis Pharma’s lead product, ATIR, helps remove alloreactive cells that can attack patients’ tissues and organs (graft versus host disease). Treatment with ATIR allows the use of mismatched donors for life-saving stem cells transplants given to end-stage patients with blood cancers, according to Frijlink.
“In a Phase II trial of ATIR, none of the nine patients treated with ATIR who received donor lymphocyte infusions after a mismatched stem cell transplant experienced host versus graft rejection,” Frijlink commented. “This is good, as patients often die from the complications of a transplant, such as an infection, rather than the cancer. If we can prevent this, we can make life-saving stem cell transplants to much larger patient groups, including those that would not even be considered for a transplant because of their age, fitness, or lack of a suitable donor.”