Alvogen Obtains First Approval for Glatiramer Acetate 40 mg/mL in Europe

- First three times weekly glatiramer 40 mg/mL

- Approval obtained, in close collaboration with partner Synthon

- Provides an affordable, high-quality alternative to MS patients, complemented by a range of support services including AutoxonTM

PINE BROOK, N.J.--()--Alvogen today announced the successful closure of the decentralized procedure for RemurelTM (glatiramer acetate) 40 mg/mL, the first generic equivalent of CopaxoneTM 40 mg/mL in Europe.

Alvogen is already successfully marketing a once daily subcutaneous 20 mg/mL prefilled syringe under the brand name RemurelTM. The approval of the generic three times weekly 40 mg/mL is excellent news for the multiple sclerosis community, providing a high-quality and affordable alternative.

Teva's CopaxoneTM delivered sales of over EUR 505 million in Europe in 2016, according to IMS Midas data.

Hacho Hatchikian, Executive Vice President at Alvogen in the CEE region, commented, "The successful DCP closure and approval of Alvogen's glatiramer acetate 40 mg/mL, therapeutically equivalent to Copaxone® 40 mg/mL, marks another significant milestone for our company, reinforcing our proven capabilities in bringing complex and difficult-to-manufacture products to market ahead of the competition, and further underlining our commitment to providing access to high-quality and affordable medicines."

About Alvogen

Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world. The company has commercial operations in 35 countries with 2,800 employees and operates four manufacturing and development hubs in the US, Romania, Korea and Taiwan. North America is Alvogen’s single largest market and other key markets include: South Korea, Russia, Hungary, Romania, Taiwan, Ukraine, Japan and China.

A consortium of investors, led by CVC Capital Partners and including Singapore-based investment company Temasek and Vatera Healthcare Partners, acquired a majority stake in Alvogen in June 2015.



Halldor Kristmannsson, (+354) 522-2900
Global Corporate Marketing & Media Relations

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Release Summary

Alvogen obtains first approval for glatiramer acetate 40 mg/mL in Europe - providing more affordable treatment for MS patients.