Cipla Gulf, Alvotech partner to commercialise AVT02 Biosimilar of AbbVie's Blockbuster drug Humira

Mumbai: Biopharmaceutical company Alvotech and Cipla Gulf FZ LLC ("Cipla Gulf"), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited today announced that Alvotech and Cipla Gulf have entered into an exclusive partnership for the commercialization of AVT02, an adalimumab biosimilar, in select emerging markets.

AVT02 is a mAb biosimilar to AbbVie's HUMIRA®, which is a leading drug indicated for the treatment of several autoimmune diseases, including (but not limited to) Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Plaque Psoriasis (PP), Psoriatic Arthritis, Ulcerative Colitis (UC), and Crohn's Disease (CD). It neutralizes the Tumor Necrosis Alpha (TNF-α) involved in systemic inflammation and the above-mentioned diseases. AbbVie's HUMIRA® recorded sales of about

US$20 billion in 2018, making it the largest-selling blockbuster medicine worldwide.

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

Robert Wessman, Alvotech's founder and Chairman said "We are very proud to announce our strategic alliance with Cipla, a leading global company with over 84 years of history. 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."

Nishant Saxena, CEO, International Business (Europe & Emerging Markets), Cipla, said "This is a significant addition to our portfolio of offerings in the global biosimilars space which includes trastuzumab, bevacizumab, etanercept and pegfilgrastim. Adalimumab 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."