In the second part of Generics Bulletin’s exclusive interview with Fresenius Kabi’s senior vice president for biosimilars in the US, Ali Ahmed, he explains why Kabi is relishing the prospect of competing in pegfilgrastim and what the acquisition of mAbxience means for the company’s prospects and vision.

Fresenius Kabi and Formycon have announced a global licensing deal for the FYB202 ustekinumab proposed biosimilar rival to Stelara. The deal comes as Formycon has revealed plans to raise further funds to funnel into research and development through a fresh share issue.

The companies unblinded data from CARTITUDE-4, which met its primary endpoint, but analysts citing KOLs said they continue to face issues with limited manufacturing slots and out-of-spec product.

Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.