In the current financial climate, with National Health Services across Western countries under increasing pressure to ‘do more with less’, biosimilar drugs are starting to attract significant attention and are likely to reshape the pharmaceutical industry as we know it. Barely surprising, if we consider that according to the RAND Corporation, biosimilars could save the U.S. health system close to $44 billion in the next ten years.
But what are Biosimilars, exactly? A biosimilar is a biological product that is similar to a reference biologic (vaccines and gene therapies, for instance) and for which there are no clinically meaningful differences in terms of safety, purity, and potency.
In 2010, President Barack Obama signed into the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), allowing an abbreviated approval pathway for biologics to encourage production, create competition, increase treatment options and reduce healthcare costs. Under the new law, a biological product may be demonstrated to be “biosimilar” if data show that the product is “highly similar” to an already-approved biological product.
We have asked Michelle Lee-Bourner, Head Biologics and Respiratory Global Regulatory at Mylan what are the major ‘hot topics’ and challenges in the approval of Biosimilar Drugs today:
“One of the key challenges is developing the capability to make biologic insulin products. Insulin production is expensive, most notably when recovering and purifying the final product large bioprocessing volumes are required to make the production of an insulin product commercially viable. To complicate matters further, companies developing follow-on insulins are currently not permitted to submit them for regulatory review through the FDA’s biosimilars approval pathway”.
Non-innovator insulins available on the U.S. market are, in fact, not classified as biosimilars, but as follow-on biologics, since their reference brands were previously approved via a New Drug Application (NDA). NDAs, otherwise known as 505(b)(1) applications, regulate quite a few biologics, including human growth hormones, follicle-stimulating hormones, and insulins. Follow-on biologics follow a similar, but shorter, NDA approval process referred to as 505(b)(2). Except for these therapeutic classes, the majority of other novel biologics are approved under a Biologics License Application (BLA), also referred to as the 351(a) pathway. Biosimilars are approved via an expedited version of a full BLA application, the 351(k) pathway.
“All biologics, however” - Michelle Lee-Bourner continues, “will be transitioned to the BLA pathway from March 23, 2020, meaning that all follow-on insulins can be approved as biosimilars after this date. We are now working relentlessly, at Mylan, to make sure that one of our products meets this FDA deadline. Busy times indeed!”.
The increased competition biosimilars provide should drive down the cost of insulin, according to the FDA. 6 million people in the United States alone depend on the Diabetes drug, and the introduction of a biosimilar insulin could be revolutionary to their healthcare needs. The policy changes cannot come fast enough: follow-on insulins available to date, including Admelog, manufactured by Sanofi and references Eli Lilly’s Humalog, has a list price of only approximately 15% less than Humalog.
Companies of the likes of Mylan, Teva, Amgen, Hospira and Sandoz are increasingly working to develop and bring to the market biosimilar products in various therapeutic areas. How quickly other players will embrace the challenge may be a game changer within the Biopharmaceutical landscape in the years to come.