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Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.
Despite proactive measures by FDA to support biosimilars, barriers still exist to their entry in the United States market, GlobalData, a data and analytics company, reported in a May 14, 2018 press release.
The slow entry of biosimilars into the US market has prompted FDA to take proactive measures, such as educating patients and physicians through online resources and information campaigns, to ensure the continued growth of the biosimilars market, generate more competition, and lower prices of biologics, according to GlobalData.
Despite the Biologics Price Competition and Innovation Act (BPCIA), implemented by FDA in 2010 to create an abbreviated pathway for biosimilar drug approval, only nine biosimilars are available on the US market to date, and it is estimated that only 3% of spending on biologics may face competition from biosimilars, according to The New England Journal of Medicine, as cited by GlobalData.
However, the recent biosimilar naming system employed by FDA presents an educational barrier. The agency’s system requires that the biosimilar include a non-proprietary name and a suffix that identifies the manufacturer in order to improve pharmacovigilance, however, this results in confusion for physicians and patients who might be led to believe that the clinical effects of the biosimilar differ from the original product, GlobalData notes.
“Without a meaningful drive to educate physicians, biosimilars are likely to be dismissed as less effective than their reference products, therefore the financial incentive for entering the biosimilar market is significantly reduced,” said Antoine Grey, MBiochem, pharma analyst at GlobalData, in a company press release.
A barrier that reduces financial incentive is the tendency of pharmacy benefit managers (PBMs) to continue favoring the original product over the biosimilar, despite discounts. This stems from the fact that the initial 15–20% discounts on biosimilars are offset by the likely small population of patients being initially moved to the biosimilar, according to the company.
“As a result, biosimilar sponsors are unable to offer large patient volume-based rebates on their products, and PBMs therefore try to limit biosimilar uptake so as to maintain rebate payments,” Grey said in the press release.
The manufacturing process for a biosimilar is another barrier. Manufacturing a biosimilar that is interchangeable with its reference product is not easy, GlobalData notes. A biosimilar designated as interchangeable can replace the reference biologic at the pharmacy without the permission of the prescribing physician, but FDA draft guidance from January 2017suggests that biosimilar manufacturers may have to conduct additional clinical studies to demonstrate that “the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alteration or switch.” As a result of FDA’s guidance, no biosimilar has yet been designated interchangeable as of April 2018, as reported by GlobalData.
Another aspect of the manufacturing barrier is that biosimilar manufacturing is more expensive and complex than generic small molecules, which have a relatively straightforward manufacturing process. Reference product producers tend to be secretive about their manufacturing practices even after patent expiry, which delays biosimilar development. Furthermore, small molecules can be characterized by analyzing their end products.
"The process is not as simple for biologics, therefore biosimilar manufacturers may struggle to replicate the reference product even with a sample of the biologic," Grey said in the press release.