Last week (Nov 2-3, 2010) FDA held its public hearing on biosimilars to get input on development of these products in the US as they devise a regulatory pathway. There was a variety of opinions expressed by a variety of constituents at the hearing. The most resounding consensus, to me, was that these products require some level of clinical studies, and that post-marketing safety / pharmacovigilance is essential.
Given the great need to cut health care costs and increase access to medicines for patients through better affordability and choice; given our advancements in science and ability to characterize these products as compared to the reference / innovator products; and given the intense focus on development of a regulatory pathway that has patients' best interests (safe and effective products) in mind, it seems to me that biosimilars make sense in the very near future as part of our US medical treatments.
Another critical consensus regarding biosimilars is the need to educate, particularly health care providers and patients, about these products. (More than likely more education is needed about biologics products in general.) In order for biosimilar products to be accepted and commercially viable, the public needs to know what they are (versus traditional drug / generic products), what value they bring and to what diseases, where else they are approved and used in the world, what manufacturers and FDA will do to help ensure biosimilars are safe, how they will be prescribed, what they cost, how the labels will identify these products, how they should be administered and any potential risks, what resources / support are available on these products, and what steps patients / providers can take to help contribute to the knowledge and safety of these products once approved and in use. Comprehensive and user friendly education, information and support on these products will help build advocacy.
Although there are other high bars set for biosimilar manufacturers in addition to the pending regulatory requirements, most likely biosimilar products will get on the market in this country; once a pathway exists, some speculate within several to five or six years for the simpler products already approved in Europe. At first they may be used for new patients going on therapy versus switching a patient from an existing biologic therapy (interchangeability; a whole other area of varying opinion and further complexity).
Biosimilars are possible today because science has progressed, and it continues to do so every day. Let's not stifle innovation in biologics. Let's encourage it. Coupled with personalized medical techniques, there is a bright outlook for more effective, safer and more affordable medical treatments for a wider variety of diseases, and innovator biologics and biosimilars will play a critical role in that evolution. I will do my best to keep myself educated on these products and their regulatory and commercial progress and share my knowledge with family, friends.
Note: these opinions are my own. I am not a regulatory expert, I just happen to know quite a few good ones. Thanks for reading.
Chris
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