Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

The Bill & Melinda Gates Foundation has extended a financial commitment of up to $120m to secure a dedicated, low-cost supply of generic molnupiravir to lower-income countries. The Gates Foundation is looking to “significantly reduce the time it takes for a new drug to reach low-income countries after it becomes available in high-income markets.”

US-based Phlow and Fresenius Kabi have announced an alliance to supply essential medicines, including injectables, for public health emergencies and to Children’s Hospital Coalition, a project by Phlow. In an exclusive interview with Generics Bulletin, Phlow chief business officer Dan Hackman talks about the partnership, addressing US supply chain disruptions, domestic manufacturing and more.

With Natco poised to debut the first batch of Revlimid generics in the US in March next year, fellow Indian ANDA sponsor Dr Reddy’s Laboratories has secured its own approval from the FDA for two strengths of the blockbuster multiple myeloma treatment.

French off-patent association Gemme has hit back after the country’s latest annual PLFSS social security legislation contained a lack of measures to boost generics and biosimilars. Three key policy proposals have been outlined by the industry body.

Zydus Cadila has failed to prove to a US court that a US patent expiring in October 2025 that shields AstraZeneca’s Farxiga (dapagliflozin) SGLT2 inhibitor is obvious, keeping the firm’s proposed ANDA product off of the market for now.

The Biosimilars Forum, in partnership with the Pacific Research Institute, has released a report that shows state-by-state cost savings for the US if biosimilars were able to capture a market share of 75%. Meanwhile, the Association for Accessible Medicines has also released its complete 2021 US Generic And Biosimilar Medicines Savings Report, discouraging reducing incentives for patent challenges and early generic entry.

Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.

Zentiva’s Zent2U B2B unit has reported progress on a bioequivalence study for its sitagliptin tablets, indicating that its version will be ready for day-one entry in Europe. The development comes shortly after Zent2U announced the successful completion of a sertraline study.