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.

Partners Apotex and Ambio have announced approval of a second US teriparatide generic from the FDA, adding another Forteo rival to the market and removing hopes that Teva’s recently approved first generic could benefit from 180 days of market exclusivity. Further competition is also in the works with Amphastar awaiting FDA action on a further teriparatide ANDA.

Partners Fresenius Kabi and Formycon have submitted a US filing for their FYB202 ustekinumab biosimilar rival to Stelara.