EMA’s “positive opinion” for Stada’s biosimilar teriparatide

STADA has received a so-called “positive opinion” for the biosimilar teriparatide from the responsible EU approval authority, EMA.

In line with the application, this “positive opinion” covers osteoporosis in men and post-menopausal women with a high fracture risk as well as the treatment of osteoporosis in men and women with a high fracture risk associated with systematic long-term glucocorticoid therapy. An EU-wide approval of teriparatide from the EU Commission is expected in January 2017, said the company in its press release issued on Monday.

STADA and Richter-Helm BioTec GmbH Co. KG (“Richter-Helm”) signed a licensing and sales agreement for the marketing of the teriparatide biosimilar in Europe in October 2014. STADA received semi-exclusive sales rights for the European Union and nine non-EU countries, while Richter has the right to sell and market teriparatide in geographical Europe and the CIS.

“Teriparatide will be a key part of our portfilio in the future. The positive opinion from the EMA is a clear indication that we have relied on the right cooperation partners for our biosimilar strategy. Despite all of the uncertainties that could have delayed the approval of this innovative medication, we are moving forward as planned with the expansion of our biosimilar business”, says Dr. Matthias Wiedenfels, Chairman of the Executive Board at STADA Arzneimittel AG, summarizing the advantages of the cooperation.

Under the terms of the agreement, in addition to a payment at the signing of the contract, STADA will also make further payments, each depending on the progress of the project. With the EU-wide launch of marketing planned to coincide with the expiration of the patent at the beginning of 2019, STADA will report the resulting sales and make further license payments to Richter-Helm, the company concluded.

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