Samsung Bioepis has celebrated the FDA’s first ever approval of an ophthalmic biosimilar with its endorsement of the firm’s Byooviz ranibizumab rival to Lucentis. The firm has also signaled a surprising expected launch date in the US, as well as offering expectations for launch in Europe where the biosimilar was also recently approved.

Regeneron's Eylea and Roche's Lucentis currently dominate the treatment market for wet-AMD and diabetic eye disease, but biosimilar ranibizumab and new brand launches are on the horizon.

Ahead of launching potentially its Lucentis biosimilar in the EU early next year, Samsung Bioepis has reported two lots of positive analysis involving its Byooviz biosimilar, at the same time as it disclosed the findings of a five-year follow-up study for its trastuzumab biosimilar, Ontruzant.

Samsung Bioepis has expanded its portfolio of biosimilar products in its domestic South Korea, with the launch of bevacizumab via partner Boryung Pharmaceutical.