Teva Expands Strategic Partnership with Alvotech Despite FDA Approval Delay for Biosimilar Drugs

Pharmaceutical giant Teva has announced its decision to further collaborate with Icelandic company Alvotech, expanding their strategic partnership despite ongoing delays in FDA approval for biosimilar drugs. The two companies had previously initiated their partnership two years ago and are now deepening their involvement in management and production.

The recent agreement between Teva and Alvotech centers around the development of two new drugs. Under the terms of the deal, Alvotech will be responsible for manufacturing the drugs, while Teva will be granted exclusive marketing rights for these medications in the United States.

In August 2020, Teva and Alvotech had signed a major agreement for the development and commercialization of five biosimilar drugs. These biosimilars, generic versions of drugs created through genetic engineering of mammalian cells or bacteria, included Humira for the treatment of rheumatoid arthritis, Crohn's, and colitis; Stelara for arthritis, Crohn's, and psoriasis; and Eylea for retinal disease treatment.

However, the anticipated approval from the US Food and Drug Administration (FDA) for the biosimilar version of Yomira, which had a whopping $17 billion in sales in the first quarter of this year, has been delayed. This FDA approval delay is likely to hamper Teva's ability to achieve its forecasted financial results for 2023, with projected revenues of $15.4-14.8 billion and an adjusted cash flow operating profit of $4.9-4.5 billion. The holdup in approval is also expected to impact Teva's market share in Yomira's sales.

The delay has been attributed to quality control deficiencies at Alvotech's manufacturing plant in Iceland, where the five drugs included in the collaboration with Teva are intended to be produced. In an effort to rectify these issues, Teva has decided to increase its involvement in production and quality control at Alvotech's Icelandic plant.

Teva's CEO, Richard Francis, expressed confidence in the partnership and its potential to deliver successful results once the FDA approval hurdles are overcome. The company remains committed to providing patients with affordable and high-quality biosimilar medications.

As both companies work towards resolving the manufacturing challenges, the pharmaceutical world watches closely for further updates on the FDA's decision and the subsequent impact on Teva and Alvotech's collaboration.