Little progress on FDA path of biosimilar biologics for RD
It’s hard to believe it’s been almost two years since we’ve discussed biosimilars on Rheumatoid Arthritis Warrior (RAW). What’s even harder to believe: the situation in the U.S. is much the same:
1) The Biologics Price Competition and Innovation Act (BPCI) was created as a pathway for FDA approval of biosimilar products, including those to treat Rheumatoid Arthritis / Rheumatoid Disease (RD).
2) A biosimilar is a biological product demonstrated to be highly similar to an already approved biological product. This is distinct from a generic, which should contain the identical chemical ingredient as an original brand. Products seeking approval as “similar” would theoretically not be any more or less effective or have different side effects than the original.
3) The law calls for an abbreviated process, but the details have yet to be clearly defined by the FDA, so there are presently no applications in process for biosimilars in the U.S.
But that doesn’t mean there’s no news on biosimilars!
1) Inflectra: 1st biosimilar for Remicade approved in Europe
Last month, the European Medicines Agency (EMA) approved Inflectra, a biosimilar version of infliximab (Remicade), for the treatment of RD and Crohn’s disease, as well as ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, and psoriasis. This is good news for South Korea’s Celltrion (see related images on RAW here) and Chicago-based Hospira, and has generated plenty of speculation about how much of the market they would be able to take from Remicade, currently marketed by Johnson & Johnson. Some hope the approval of Inflectra will bring a reduction in price for the brand product or drive other biologic prices down. Celltrion created this first biosimilar monoclonal antibody drug to be approved in Europe, and Hospira, “a leader in injectable and infusion technologies,” will market Inflectra. The question is what U.S. patients/customers might expect when the U.S. patent expires for Remicade in 2015.
2) Other biosimilars get closer to approval in Europe
A biosimilar version of Amgen’s Enbrel, owned by Sandoz, is beginning phase III trials in Europe for psoriasis. If Sandoz’s compound is proven to be sufficiently similar to Enbrel in treating psoriasis, approval might be easier to gain for other conditions like RD. The trial should be completed by November 2015.
3) Big pharma companies who already own blockbuster drugs are expanding into the biosimilar market.
As far as I can see, Pfizer has its hand in three different biosimilars. Pfizer is conducting trials for versions of adalimumab (Humira), infliximab (Remicade), and rituximab (Rituxan).
AbbVie purchased Ablynx’s nanobody reengineered llama antibody, currently called ALX-0061.
Amgen is to start a phase III trial of a biosimilar to adalimumab (Humira).
It’s going to be complicated to keep track of all the different compounds being tested or marketed by different pharma companies, like a game of musical chairs. No way to know which drugs will finally be approved or who will own them at that point, and which one will be the biggest winner. Companies can hedge their bets by placing their stakes on more than one at a time.
Read more about trials for new treatments in the pipeline from Pfizer and other pharma companies on a new RAW page, New Rheumatoid Arthritis Treatments in the Research Pipeline.
There’s sure to be much to report on Biosimilars from the ACR scientific meeting later this month and RAW will be there to get the scoop for you.
RELATED RESOURCES ON RAW
LIST OF TREATMENTS APPROVED FOR RHEUMATOID ARTHRITIS: Rheumatoid Arthritis Treatments
LIST OF TREATMENTS CURRENTLY IN THE PIPELINE FOR U.S. APPROVAL FOR RD: New Rheumatoid Arthritis Treatments in the Research Pipeline
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