Alvotech, Cipla Create Partnership to Sell Adalimumab Biosimilar

Biopharmaceutical company Alvotech and Cipla Gulf entered into an exclusive partnership for the commercialization of AVT02, an adalimumab biosimilar, in certain emerging markets, the companies reported Monday. Alvotech's AVT02 is in phase 3 trials; the companies expect to file for approval with the European Medicines Agency and the FDA by early next year.

AVT02 is a biosimilar to AbbVie's originator product, Humira. Last week on an earnings call, AbbVie revealed that, in the United States, Humira sales grew by $3.8 billion last quarter, up 7.7% from the prior year, with volume growth of approximately 7%. However, in international markets, where adalimumab biosimilars are more readily available, sales of Humira fell by $1.1 billion, or 31% on an operational basis.

Cipla is one of several generic drug makers in India that is retooling in order to create biosimilars. It has other agreements with Prestige BioPharma for a trastuzumab biosimilar and Bio-Thera for a proposed bevacizumab biosimilar.

Under the partnership announced Monday, Alvotech will be responsible for development and supply of the product; Cipla Gulf will be responsible for registration and commercialization.

“We are very proud to announce our strategic alliance with Cipla, a leading global company with over 84 years of history,” said Robert Wessman, Alvotech's founder and chairman, in a statement. "By partnering with Cipla, Alvotech gains access to Cipla's strong commercial network in select emerging markets and deep market experience, which will ultimately benefit patients who will get better access to high-quality biosimilars."

"This is a significant addition to our portfolio of offerings in the global biosimilars space which includes trastuzumab, bevacizumab, etanercept, and pegfilgrastim,” said Cipla’s Nishant Saxena, chief executive officer, international business (Europe and emerging markets). “Adalimumab is the highest-selling pharmaceutical product in the world and the preferred anti-inflammatory treatment option for several autoimmune diseases.”