Cipla, Alvotech in pact for commercialisation of Humira biosimilar

Mumbai | Updated on July 29, 2019 Published on July 29, 2019

In its second deal in about two week weeks, drugmaker Cipla has forged an exclusive partnership with biopharmaceutical company, Alvotech, for the commercialisation of AVT02, an adalimumab biosimilar, in select emerging markets.

AVT02 is a biosimilar version of AbbVie’s HUMIRA, used in treating autoimmune diseases, including rheumatoid arthritis and plaque psoriasis (PP), among others. It neutralises the Tumor Necrosis Alpha involved in a systemic inflammation, a note from the company explained. AbbVie’s HUMIRA clocked revenues of $20 billion in 2018, making it among the largest-selling blockbuster medicine globally.

In this partnership, Alvotech will be responsible for the development and supply of the product, while Cipla Gulf, a wholly owned subsidiary of the Mumbai-based drugmaker will be responsible for registration and commercialisation. Alvotech’s AVT02 is in its third phase of clinical development ahead of filing with the European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) by early 2020, the company said.

Last week, Cipla had, through its wholly-owned subsidiary, in the US, announced the acquisition of prescription drug Zemdri (Plazomicin) from Achaogen Inc. The transaction was through a Chapter 11, US Bankruptcy Code auction of Achaogen’s assets, the company said. The transaction involved the acquisition of worldwide rights of Zemdri (excluding Greater China) with its allied assets and limited liabilities. The product is an anti-infective used to treat complicated urinary tract infections (cUTI), among other things. Approved by the United States Food & Drug Administration (USFDA) in June 2018, and launched in the same year, the patent protection on the drug was expected to continue until 2031 or 2032, Cipla said.

Biosimilar deal

In the latest biosimilar deal, Robert Wessman, Alvotech’s founder and Chairman, said the transaction would give them access to Cipla’s commercial network in select emerging markets and deep market experience. Nishant Saxena, Cipla’s Chief Executive Officer, International Business (Europe & Emerging Markets), said Adalimumab was the highest-selling pharmaceutical product in the world and the preferred anti-inflammatory treatment option for several autoimmune diseases. Its addition would strengthen Cipla’s biosimilars portfolio that included trastuzumab, bevacizumab, etanercept and pegfilgrastim.

Published on July 29, 2019
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