Teva Pharmaceuticals announced entering into an exclusive commercialization agreement with Bioeq for the latter’s ranibizumab (Lucentis®) biosimilar in Europe, Canada, Israel and New Zealand. As part of the licensing agreement, Bioeq will be responsible for the development, registration and supply of biosimilar and Teva will be responsible for commercialization and marketing.
Bioeq has in-licensed the ranibizumab (Lucentis®) biosimilar candidate from Formycon AG and holds exclusive global commercialization rights for the biosimilar. Last year, Bioeq forged exclusive license for US commercialization rights for the biosimilar to Coherus Biosciences and Coherus plans on submitting the BLA to US FDA in mid-2021 to seek marketing authorization. The candidate is now in late-stage phase-3 trials and preliminary data points to comparable efficacy to Lucentis®.
This is a second such deal for Teva, as it previously licensed 5 biosimilars from Alvotech last year for the US market. The deal is an emphatic example of strategic partnerships in the biosimilars space. Time-sensitivity of biosimilar development, regulatory detailing and clinical data requirement make biosimilar programs fraught with uncertainty, and such strategic partnerships can help de-risk part of the development journey for potential marketers. While Teva doesn’t have any in-house biosimilar pipeline, it has a substantial ground force globally on account of its generics business. Teva currently markets trastuzumab and rituximab biosimilars in the US and select international markets. It will be able to leverage its extensive distribution and marketing network across Europe, Canada and other international markets to commercialize the biosimilar.
Established players in the global generics business are now vying to get a slice of the biosimilars pie. Notable recent biosimilar partnerships have been Cipla’s partnership with Alvotech and Mylan’s partnership with Biocon and Lupin for multiple biosimilar candidates. Biosimilars market are maturing now globally, compounded by more regulatory clarity and greater confidence of the prescribers, hence, late entry into the game will not a disadvantage for players not aiming to enter the biosimilars business now. Strategic partnerships such as these can help these companies get a feel of the market and make critical decisions on building an in-house pipeline or continuing the partnership route to expand portfolio.