Stada and Alvotech have announced the launch of the Hukyndra higher-strength adalimumab biosimilar rival to Humira in selected European countries, with a wider roll-out to follow in the coming months.

Xbrane Biopharma has withdrawn the BLA for its proposed Xlucane ranibizumab biosimilar rival to Lucentis in the US after the FDA said further information was required for it to accept the filing. Development partner Stada said it would “work closely” with Xbrane and US licensee Bausch + Lomb to get the product to market.

The EMA’s CHMP has issued a positive opinion for the Kinpeygo budesonide 4mg modified-release hard capsules hybrid medicine developed by Calliditas that will be marketed in Europe by Stada. Meanwhile, four generics from Accord, Fresenius Kabi, Gedeon Richter and Sun have also been endorsed by the committee.

The European Medicines Agency has delivered its verdict on the latest medicines it believes should be approved for marketing in the EU. By contrast, it has given the thumbs down to one biosimilar anticancer drug and its duplicate.