Biosimilar Business Recap: Progress for Insulin in Europe, Canada; Biocon Biologics' Viatris Acquisition Completed

Capstone has announced that its human insulin biosimilar received positive opinions from the European Medicines Agency and Health Canada, signaling approvals may be on the horizon, and the acquisition of Viatris’ biosimilars portfolio by Biocon Biologics is officially complete.

European and Canadian Insulin Progress

Capstone Development Services Company shared that its biosimilar human insulin received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, sending it on to the European Commission for final review before approval. Additionally, the same biosimilar received a Notice of Compliance from Health Canada, meaning that the product has been approved for use.

The biosimilar was developed by Capstone’s affiliate company, Celerity Pharmaceuticals, and is formulated as an intravenous infusion in a flexible plastic container in 0.9% sodium chloride injection. If approved, the biosimilar could be administered to patients in hospitals and other acute settings.

The European and Canadian filings represent the 17th and 18th regulatory processes that Capstone has participated in for products developed in partnership with global pharmaceutical and medical organizations since 2013, when Capstone was founded.

“We are honored to be part of successfully developing this innovative presentation of insulin to advance our partner's goal of introducing medicines that help promote efficiency for clinicians and provide patients with a better experience,” said Dan Robins, PhD, president of Capstone.

Biocon Biologics Acquisition of Viatris’ Biosimilars Completed

Viatris announced that its transaction with Biocon Biologics Limited is closed, officially completing the transition of Viatris’ entire biosimilars portfolio to Biocon Biologics.

The companies entered a Transition Services Agreement in March 2022, during which Viatris will provide commercialization assistance and transition services for a 2-year period to ensure business continuity for patients and other stakeholders. Biocon Biologics will be responsible for commercial, regulatory, and other related services.

“The closing of our biosimilars transaction with Biocon Biologics marks the next natural step in the evolution of our collaboration together… As we look to Viatris' future, we are also excited to focus our energy, resources, and efforts on executing our own strategy of moving up the value chain and providing access to more complex and novel products,” commented Rajiv Malik, MPharm, president of Viatris.

As part of the agreement, Viatris received $3 billion in consideration, including at least a 12.9% stake valued at $1 billion in Biocon Biologics. Viatris will also receive an additional cash payment of $335 million in 2024.

In 2022, Viatris and Biocon Biologics launched Abevmy, a bevacizumab biosimilar referencing Avastin, in Canada for the treatment of several forms of cancer. Viatris, which resulted from the completion of a merger between Mylan Pharmaceuticals and Upjoin, also had to recall particular batches of its unbranded insulin glargine biosimilar twice this year.

Viatris and its partner Momenta Pharmaceuticals shared positive results from the phase 3 INSIGHT study evaluating the safety and efficacy of an aflibercept biosimilar candidate (MYL-1701P) referencing Eylea at the American Academy of Ophthalmology’s annual conference.

In November 2022, Biocon, Biocon Biologic’s parent company, shared its quarterly revenues report, revealing that Biocon Biologics’ revenue from biosimilars was up 34% year over year. The company also licensed out 2 of its biosimilars, an ustekinumab and a denosumab, to Yoshindo for the Japanese market.