Urtė Fultinavičiūtė

Opuviz is now available in Europe in both vial and pre-filled syringe presentations, completing Samsung Bioepis' ophthalmology offering in the growing aflibercept market.

Amneal has completed its acquisition of Kashiv BioSciences, creating what it calls one of the industry's few fully integrated biosimilar platforms.

Mabwell has secured four new commercialization deals for its aflibercept biosimilar across the GCC and ASEAN regions, while its wholly owned subsidiary T-mab passed a second PIC/S GMP inspection for its denosumab biosimilars.

Formycon confirmed its full-year revenue guidance of €60m–€70m, leaning on expected growth from the underperforming ustekinumab and far-from-launch but promising pembrolizumab biosimilars.

Outlook Therapeutics is exploring a pre-filled syringe version of its ophthalmic bevacizumab Lytenava, while eyeing Latin America, Asia, and MENA for further deals.

Outlook Therapeutics is positioning Lytenava as the only FDA-approved ophthalmic bevacizumab, occupying a distinct space from biosimilars used off-label in the US retina market.

The latest FDA approval of a fluticasone propionate nasal spray further secures Glenmark's ambition to resurrect its US presence with an expansive respiratory product portfolio.

Teva has settled patent infringement litigation with Aurinia Pharmaceuticals over Lupkynis (voclosporin), securing the right to launch its generic version one year before the two disputed dosing method patents expire in December 2037.

Generics Bulletin's senior reporter Urtė Fultinavičiūtė is joined by Wilna Lottering and her son Josh from South Africa, as well as Gayle Pledger, a cystic fibrosis campaigner, who share their journey of navigating the patent system to find a generic cystic fibrosis drug.

With no FDA-approved treatment for female sexual arousal disorder, Daré Bioscience is entering an unaddressed market by developing a 505(b)(2) sildenafil cream, while concurrently launching a 503B compounded version.