Upsher-Smith has strengthened its US generics portfolio with three new launches that will compete in a combined market worth nearly $102.5m.

With the pre-GDUFA backlog largely acted upon, the FDA expects ANDA approvals to decrease, but supplement actions to increase in FY 2020 and FY 2021.

Sandoz US president Carol Lynch talked to Scrip about its changing US portfolio, which will emphasize biosimilars, as the Novartis unit is poised to divest most of its US generics portfolio to Aurobindo.

Bangladesh’s Beximco will market Mylan’s biosimilars in its domestic market, under a deal that has just been struck between the two companies. The Ogivri trastuzumab biosimilar, co-developed by Mylan and Biocon, will be the first product launched as part of the collaboration.

Belgian off-patent industry association Medaxes has set out its aspirations for a new biosimilars taskforce that has been set up by local health insurance body INAMI. Data cited by the industry body shows that biosimilar penetration in Belgium is still lagging behind that of its European neighbors.

A strong tailwind from antipsychotic drug Vraylar helped Hungary’s Gedeon Richter to post a 40% leap in 2019 net profit. Analysts see more upside ahead for eastern Europe’s largest drugmaker.

Complex generics and value added medicines share common challenges on harmonization of regulation, lack of incentives and clarity of guidelines, heard delegates to Medicines for Europe’s Regulatory & Scientific Affairs conference.

Quarterly global Basaglar sales rose above $300m for the first time in the fourth quarter of 2019, with full-year turnover pushing the insulin glargine hybrid well into blockbuster territory.

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