Generics Bulletin - News And Expert Analysis On Generics And Biosimilars since 2003

As Amarin and Hikma continue to file briefs with the Supreme Court ahead of oral arguments at the end of this month in their skinny-label induced-infringement litigation over carve-outs for generic Vascepa (icosapent ethyl), the latest development sees Hikma attacking Amarin’s 'safe harbor' claims.

Mabwell has signed a Malaysian licensing deal for its denosumab biosimilars Mailishu and Maiweijian, further expanding its footprint in Southeast Asia.

Amneal has launched its first US metered-dose inhalers, introducing generics to ProAir and legacy QVAR products as legal wins, patent scrutiny, and regulatory shifts further open a long-protected respiratory market.

Mochida has partnered with Qilu Pharmaceutical to develop and commercialize a follitropin alfa IVF biosimilar in Japan, marking its entry into reproductive medicine biosimilars and targeting an underpenetrated but growing fertility market.

Japan’s Towa has signed a basic agreement with Adragos Pharma Kawagoe to expand manufacturing capacity, using outsourcing, parallel production and cross-company collaboration to stabilize supply of off-patent medicines and support broader industry reform.

Sandoz has signed a direct supply and manufacturing agreement with Rwanda to deliver around 60 essential medicines, positioning the country as a regional access hub while linking European antibiotic production capacity to growing demand across African markets.

Apotex said the approval of the generic vitamin combination injectable reflects the strong collaboration model it has with its partners Orbicular and Gland Pharma.