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Biosimilar Regulatory Roundup: February 2022


February kicked off with a number of regulatory updates from around the world, including the FDA acceptance of applications for interchangeable adalimumab biosimilars, Health Canada’s approval of Ontruzant, and more.

February kicked off with a number of regulatory updates from around the world, including the FDA acceptance of applications for interchangeable adalimumab biosimilars, Health Canada’s approval of Ontruzant, and more.

US Puts Larger Focus on Interchangeability

The first large piece of regulatory news for the United States involved the Senate vote for Robert Califf, MD, to serve as FDA commissioner. Califf narrowly won approval during the vote, obtaining a 50-to-46 split, with 6 supporting Republicans and 5 dissenting Democrats. One senator opposed to Califf’s nomination voted “present” out of deference for another senator who was unable to attend the vote.

Califf, a cardiologist and a founder of the Duke Clinical Research Institute, led the FDA during the final 11 months of the Obama administration and was nominated again for the role in November 2021. The Association for Accessible Medicines (AAM) announced support for Califf, saying that it stands ready to work with him to ensure greater access and adoption of biosimilars and generic medicines.

Additionally, a panel discussion during the AAM Access! 2022 Annual Meeting dove into the many regulatory actions that policymakers could take to address confusion surrounding interchangeability designations for biosimilars. The speakers suggested actions including modeling Europe’s tender systems, increasing education about what the designation means, and creating a consensus between state and federal governments to get rid of interchangeability barriers.

Furthermore, the FDA accepted applications for 2 adalimumab biosimilars that reference Humira for interchangeability status from Alvotech and Pfizer. Alvotech’s biologics license application is for its high-concentration, citrate-free 100-mg/mL adalimumab biosimilar (AVT02), and the company is hoping for full FDA approval along with the designation. Pfizer’s application concerns a low-concentration biosimilar.

Canada’s Great Push for Biosimilars

For the entire nation, Health Canada announced the approval of Samsung Bioepis’ trastuzumab biosimilar (Ontruzant), which references Herceptin. The approval covers the 150-mg single-dose vial and the 440-mg multidose vial for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. Ontruzant represents the fifth Samsung Bioepis biosimilar and the third trastuzumab biosmilar to be approved for the Canadian market.

Shortly after the approval, Nova Scotia became the fifth Canadian province to announce the implementation of a biosimilar switching program. The province follows British Columbia, New Brunswick, Alberta, Quebec, and the Northwest Territories. The program will apply to patients who are currently taking or will begin using adalimumab, etanercept, infliximab, insulin products, and rituximab products.

Europe Expands Biosimilar Reach

In Europe, data from Iceland showed that a switch from Humira to Samsung Bioepis’ adalimumab biosimilar, Imraldi, demonstrated difficulties with the injection device and contained citrate, a chemical buffer that is intended to maintain medication stability. The switches occurred as part of the country’s adoption of a national health plan that required patients to switch from the reference product to a biosimilar. Imraldi has a different injection device than the originator, which is heavier and does not feature an activator button, making the medication more difficult to inject.

On a greater European level, Prestige Biopharma received a European Union Good Manufacturing Practices certification for its facility that manufactures Tuznue, the company’s trastuzumab biosimilar candidate. The certification represents one of the highest standards of pharmaceutical production globally and gives Prestige a clear path to market their therapies in Europe.

Tuznue references Herceptin and can be used to treat patients with human epidermal growth factor receptor 2–positive breast cancer and metastatic gastric cancer. The drug is under review for marketing authorization by the European Medicines Agency as well as regulatory agencies in Canada and the Republic of Korea.

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