Cipla Gulf, Alvotech ink commercialisation pact for Humira biosimilar in select emerging mkts

Drug major Cipla on Monday said its subsidiary Cipla Gulf FZ LLC and biopharmaceutical company Alvotech have entered into an exclusive partnership for the commercialisation of AVT02, a biosimilar indicated for the treatment of several autoimmune diseases, in select emerging markets.

AVT02 is a biosimilar to AbbVie's Humira, which is a drug indicated for the treatment of several autoimmune diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), plaque psoriasis (PP), psoriatic arthritis, ulcerative colitis (UC), and crohn's Disease (CD).

"Under the partnership, Alvotech will be responsible for development and supply of the product, while Cipla Gulf will be responsible for registration and commercialisation," Cipla said in a regulatory filing.

Alvotech's founder and Chairman Robert Wessman said: "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".

"Alvotech's AVT02 is in phase-3 clinical development ahead of filing with the European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) by early 2020," the company added.

Cipla CEO, International Business (Europe & Emerging Markets) Nishant Saxena said this is a significant addition to the company's portfolio of offerings in the global biosimilars space.

"Adalimumab (Humira) is the highest-selling pharmaceutical product in the world and the preferred anti-inflammatory treatment option for several autoimmune diseases. We look forward to partnering with Alvotech and leveraging our own strong commercial strengths and capabilities to make this highly effective treatment option available to patients in several countries," he added.

Cipla said AbbVie's Humira recorded sales of about USD 20 billion in 2018, making it the largest-selling blockbuster medicine worldwide.

Shares of Cipla were trading 1.30 per cent lower at Rs 525.55 apiece on BSE.