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Biosimilar Regulatory Roundup: November 2022


In November, several global agencies progressed insulin biosimilars, the European Union approved another ranibizumab biosimilar, and a US Senate bill to rid switching study requirements for interchangeability was introduced to Congress.

In November, several global agencies progressed insulin biosimilars, the European Union approved another ranibizumab biosimilar, and a US Senate bill to rid switching study requirements for interchangeability was introduced in Congress.

Progress for Insulin Biosimilars

The FDA granted an interchangeability designation to Eli Lilly’s Rezvoglar, an insulin glargine biosimilar referencing Lantus. The biosimilar was originally approved in December 2021 and is the second insulin glargine biosimilar and the fourth biosimilar overall to receive an interchangeability designation.

Most recently, Capstone Development Services Company announced the Canadian approval of its human insulin biosimilar. The company also received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, sending it to the European Commission for final review before approval.

Other Regulatory Approvals

In addition to human insulin, the European Union approved Ximluci, the third biosimilar referencing Lucentis (ranibizumab) to be approved by the European Commission. The biosimilar was created through a partnership between STADA Arzneimittel and Xbrane Biopharma and would be used to treat several retinal conditions, including age-related macular degeneration and macular edema.

In Australia, Alvotech obtained regulatory approval for its adalimumab biosimilar referencing Humira (AVT02). It is the seventh adalimumab biosimilar and the 43rd overall to be approved by the Australian Therapeutic Goods Administration. AVT02 will be marked under 2 names (Ciptunec, Ardalicip) when it enters the market.

Another global approval hailed from China, where the National Medical Products Administration approved Boyobei, the first biosimilar referencing Xgeva/Prolia (denosumab) to receive regulatory approval around the world. The product was developed by Luye Pharma Group in conjunction with Boan Biotech for the treatment of postmenopausal women with osteoporosis at increased risk of fracture.

The news accompanied the announcement of 2 Canadian launches from Organon, a bevacizumab biosimilar and a trastuzumab biosimilar, and the announcement that Optum Rx was going to add 3 adalimumab biosimilars to formulary at parity with Humira.

Bills and Regulatory Policy

In Congress, the Biosimilar Red Tape Elimination Act was introduced in the Senate. The bill is seeking to increase patient access to biosimilars by making it easier for companies to obtain an interchangeability designation for biosimilars.

For biosimilars to be deemed interchangeable, in most cases, the biosimilar must be tested in costly and timely switching studies. If the bill becomes law, the switching study requirement for interchangeability would be removed.

Furthermore, the FDA launched a biosimilar regulatory science program, which is expected to help progress biosimilar development and simplfy the evaluation process for interchangeability status. The program enables the FDA to make a myriad of changes that Sarfaraz K. Niazi, PhD, argued signals a noteworthy shift in the agency’s priorities. Niazi broke down the changes and their significance in the most recent installment of his column.

Finally, for a podcast episode of Not So Different, The Center for Biosimilars® interviewed Craig Burton, senior vice president of policy and strategic alliances at the Association for Accessible Medicines, about recent actions from the Biden Administration regarding biosimilars and whether they do enough to help biosimilar competition and adoption.

Burton discussed the impact of the reauthorization of the Biosimilars User Fee Act of 2022, the Inflation Reduction Act, the FDA’s October Workshop, the federal investigation into pharmacy benefit manager practices, and the president’s public commitment to investing in biotechnology.

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