Biosimilar Rheumatology Roundup: March 2022

During the month of March, rheumatology biosimilars have received a lot of praise in a regulatory, business, and legal sense, especially regarding the landmark settlement between Alvotech and AbbVie over an adalimumab biosimilar.

Alvotech announced that it had settled with AbbVie, the maker of reference adalimumab (Humira), allowing for the biosimilar (AVT02) to enter the US market in July 2023 if the drug is approved by the FDA. The settlement resolved all pending legal disputes between the 2 companies relating to the adalimumab biosimilar, including 1 case that involved the International Trade Commission, in which AbbVie contested that Alvotech developed its biosimilar through theft of trade secrets. AbbVie’s long list of patent infringement cases have resulted in the delay of 7 FDA-approved adalimumab biosimilars from entering the market until 2023.

AVT02 had the potential to be the second adalimumab biosimilar to receive an interchangeability designation, and the potentially the first high-concentration citrate-free formulation to be declared interchangeable, pending approval.

Additionally, Shanghai Henlius Biotech signed an agreement with Getz Pharma Limited for the commercialization of an adalimumab biosimilar (HLX03) for several countries throughout Asia and Africa. HLX03 is the first self-developed monoclonal antibody for autoimmune treatment.Humira has been approved for more than 10 indications worldwide and is listed as a recommended drug in guidelines for autoimmune disease management in North America and Europe.

In other business news, as part of a new partnership between Biocon Biologics and Viatris, the former will be acquiring the latter’s biosimilar portfolio for up to $3.3 billion. The portfolio includes an adalimumab biosimilar (Hulio), an etanercept biosimilar (Nepexto), and a trastuzumab biosimilar (Ogivri). The 2 companies also share the commercialization rights for a bevacizumab biosimilar.

Under the agreement, Biocon Biologics will realize full revenues and profit from the business and Viatris will assist with any commercialization and other transition services during the first 2 years to ensure a smooth transition of the portfolio to Biocon Biologics.

The regulatory advancement of rheumatology biosimilars during March primarily occurred in China. China’s National Medicinal Products Administration (NMPA) approved 3 rheumatology biosimilars and expanded indications for another. The approvals were for a rituximab biosimilar (Hanlikon) and 2 adalimumab biosimilar (Tabovi and Junmaikang). In the United States, Junmaikang will be marketed under the name Yusimry when it launches.

Shanghai Henlius Biotech’s rituximab biosimilar also got an expanded indication for use in combination with methotrexate for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis who have had inadequate response to 1 or more tumor necrosis factor-alpha antagonist therapies. The expansion provided an alternative treatment option for patients with autoimmune disease who have not had success taking other medications, such as adalimumab.

In the United States, HHS and FDA made advancements for clinical trials that will provide more information on biosimilar use among senior citizens. The HHS Office of Inspector General said that it will conduct a study on the frequency of use and the spending associated with biosimilars in all clinical spaces, including rheumatology, within Medicare Part B plans. Many of the patients who use rheumatology medications are of an advanced age. The study is expected to start in 2023 and will present the use and spending trends of biosimilars compared with their reference products covered by Part B over time.

Finally, a case study found that patients with ankylosing spondylitis and ulcerative colitis should be carefully monitored during treatment, after a 45-year-old man was diagnosed with polychondritis after administration of an infliximab biosimilar.