Biosimilars

Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.

Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.

Biocon has made two key appointments to the management team of Biocon Biologics following a recent change in CEO for the biosimilars business.

Biocon Biologics has announced the latest milestone in its integration of former partner Viatris’s biosimilars business, completing the move in the US and Canada “ahead of schedule.”

While Celltrion has delivered an unimpressive first quarter of 2021, the company has pointed to plans to launch high-margin products in new markets. The Korean firm said that it was looking to launch its subcutaneous Remsima SC infliximab formulation in Canada and Australia in 2021, while it is also aiming to launch its Yuflyma (adalimumab) in more than 70% of the EU adalimumab market.

Formycon and partner Bioeq have offered further details on timing for the submission of their FYB201 proposed ranibizumab biosimilar version of Lucentis in Europe, the US and elsewhere.

Hikma CEO Siggi Olafsson has outlined the potential future opportunity that the firm sees in the US biosimilars market, in the second part of an exclusive interview with Generics Bulletin.

Shanghai Henlius Biotech is planning to move forward with wet AMD trials for its bevacizumab biosimilar rival to Avastin following a nod from the US FDA.

From 20 October, a free online platform will allow registrants attending the digital Global Generics & Biosimilars Awards 2020 to participate in two weeks of dedicated networking activities ahead of the ceremony on 3 November.

A draft guidance document opened for comment by the FDA offers additional Q&As on issues around biosimilar applications and interchangeability.

Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020. 

Amgen has asserted 34 patents for alleged infringement against Samsung Bioepis, which is the highest number out of the three lawsuits filed by the originator against a denosumab biosimilar maker.

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China’s Bio-Thera Solutions and Russia’s Pharmapark have struck a deal to expand their existing biosimilars collaboration for Russia and the Commonwealth of Independent States with a further candidate: the Chinese firm’s BAT2306 proposed secukinumab biosimilar to Cosentyx.

Momentum in Europe may see the region’s contribution to Glenmark’s revenues become almost as big as the US business, currently dented by multiple challenges. The firm also outlines how things are poised in India for its biosimilar to Novo Nordisk’s Victoza.

Express Scripts has announced plans to drop branded Humira from formularies in the US next year, in favor of biosimilar adalimumab rivals. The move comes after a similar decision from fellow pharmacy benefit manager CVS Caremark earlier this year, which has already boosted biosimilars significantly.

The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

The latest figures on uptake of rivals to AbbVie's Humira in the US show adalimumab biosimilars beginning to capture significant market share from the originator after an initially slow start in 2023.