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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.
Despite seeing an 8% drop in global turnover in 2019, an upbeat Teva says the completion of its restructuring plan has positioned the company to increase its turnover through newly-launched products – including biosimilars, brands and new generics – as well as improve its profit margins through manufacturing optimization.
Sawai’s sales increased on the back of a good performance from recently-launched products in the first nine months of its financial year. However, given the competitive environment the Japanese company is continuing to stick to its full-year forecasts.
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.
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