Biosimilars Business News Recap: A New Partnership; Celltrion Wins Tenders

As Sandoz and Just-Evotec Biologics announce a new partnership, Celltrion secures tender wins in Italy and Belgium, and Alvotech begins testing its golimumab biosimilar in patients with rheumatoid arthritis.

Sandoz and Just-Evotec Biologics Partnership

Sandoz and Just-Evotec Biologics announced that they will join forces for a multiyear collaboration to develop and manufacture multiple biosimilar products. The partnership will grand Sandoz access to Just-Evotec Biologics’ proprietary drug substance development platform and manufacturing technology.

Sandoz will use Just-Evotec Biologics’ resources to expand its current biosimilar pipeline from 15 products to 24 products. Just-Evotec Biologics will receive a “double-digit-million figure upfront” followed by $640 million in future payments that would be dependent on successful developments progress. The company will also receive additional undisclosed payments based on commercial manufacturing progress.

“This strategic partnership is founded on a strong shared sense of purpose and commitment to use disruptive technology with lower operational costs to deliver high-quality biosimilars at scale to patients around the world. It provides us with additional capabilities to support the strategic expansion of our pipeline with new assets and to begin immediately transitioning our early biosimilar pipeline,” said Richard Saynor, CEO of Sandoz.

Celltrion Wins Tenders

Celltrion Healthcare said it won bids in Belgium and 3 provinces in Italy to supply its bevacizumab biosimilar (Vegzelma) for the treatment of metastatic colorectal and breast cancer, according to a report from Korea Biomedical Review.

The Italian tender will last for 2 to 3 years in Lombardy, Emilia Romagna, and Toscana. The Belgian tender will last for 2 years and apply to the Brugge Regional Hospital Group and the Onze Lieve Vrouw General Hospital.

“Since expanding direct sales to all products in Europe last year, we have been achieving significant results in the bidding market based on the local subsidiary's flexible pricing policy and synergies with the performance of our existing anti-cancer products,” said Yoo Won-sik, the general manager of Celltrion Healthcare Italy, in a statement.

Alvotech Begins Golimumab Clinical Trial

Alvotech shared that it initiated a confirmatory study for AVT05, a biosimilar that references Simponi and Simponi Aria (golimumab). The objective of the study is to compare the safety, efficacy, and immunogenicity profiles between the biosimilar and reference product in patients with moderate to severe rheumatoid arthritis.

The study is a randomized, double-blind, 2-arm, multicenter trial and will evaluate both products through 16 weeks. The news comes after Alvotech announced that it began a pharmacokinetic study for AVT05 in January 2023.

“It is a pleasure to be able to mark another clinical milestone in our biosimilars development pipeline…. This is part of our strong commitment to improve patient lives by expanding access to affordable biologics globally,” said Joseph McClellan, chief scientific officer at Alvotech, in a statement.