| Pharmaceutical company Adalvo today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Livogiva, indicated for use in postmenopausal women with osteoporosis who are at high risk of having bone fractures. Livogiva is teriparatide injection, previously referred to as PF708., and it is a biosimilar product candidate to the reference medicine Forsteo (teriparatide injection), approved and marketed by Eli Lilly and Company for the treatment of osteoporosis in certain patients with a high risk for fracture. The CHMP’s recommendation will now be considered by the European Commission, Adalvo said in the press release. Adalvo (on behalf of Alvogen) and Pfenex enterered into an exclusive agreement in June 2018, granting Adalvo/Alvogen exclusive rights to commercialize Pfenex’s lead drug candidate, PF708, a teriparatide therapeutic equivalent candidate to Eli Lilly’s Forteo, in the United States. |
| Anil Okay, General Manager of Adalvo, expressed excitement by the potential market opportunity that Livogiva, if granted marketing authorization by the European Commission, may offer as a biosimilar to Forsteo® and the potential to enhance patient access to this important product. Okay said that if the marketing authorozation is granted, it would represent the company’s first marketing authorization for a biosimilar productapproval and underlines significant market access capabilities for Adalvo that deals with complex product filings and registrations in global markets. Okay is also pleased with the partnership with a leading commercial player in the LATAM region to commercialize PF708, upon granting of applicable marketing authorizations, to potentially offer an alternative solution to patients in additional countries. |
| If the European Commission affirms the CHMP opinion, it will grant a centralized conditional marketing authorization, with unified labeling that is valid in the 27 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. The version of Livogiva that is approved for marketing in the United States is Teriparatide Injection (previously referred to as PF708, as well as Bonsity), which the U.S. Food and Drug Administration continues to evaluate for therapeutic equivalence to its reference drug Forteo, the company said in the press release. |
| “Both the positive opinion from CHMP and the new commercialization agreement in Latin America represent important progress toward the global licensure and commercialization of PF708, which has the potential to improve patient access to this important drug throughout the world,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex. |