We have covered biosimilars in this blog before. Biosimilars are biological products that are similar in potency, safety and efficacy to approved reference (or “innovator”) products, but are manufactured by other companies and are intended to compete for market share with the innovator product. Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biosimilars. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. However, it turns out that in addition to the regulatory hurdle, there is an independent legal hurdle that must be overcome in bringing a biosimilar to market. In addition to FDA approval, intellectual property held by the manufacturer of the innovator product must be cleared. Increasingly, this legal hurdle is becoming front-page news as it restricts public access to biosimilars. The tumor necrosis factor inhibiting mAb adalimumab (Humira) is a case in point. Manufactured by Abbvie, Humira is the highest grossing biologic medicine, with 2017 global sales of $18.4 billion, with several biosimilar versions nearing the market. Reported by Alex Keown of biospace.com on 1 November 2018, FDA approved Hyrimoz (adalimumab), a Humira biosimilar developed by Sandoz, a subsidiary of Novartis. Hyrimoz is approved for treating autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
Abbvie’s intellectual property (IP) creates a barrier to market entry for Sandoz. Thus, Sandoz has been negotiating with Abbvie to overcome the IP hurdle. Notwithstanding regulatory approval from FDA, Hyrimoz will not be available until 2023 due to its IP litigation with Abbvie. To read more about this fascinating story about biosimilars and their challenges as available treatments in the U.S., please refer to https://www.biospace.com/article/fda-approves-humira-biosimilar-that-won-t-be-available-until-2023/.
Chamow & Associates assists companies to develop biologics for clinical testing and welcomes your inquiry.