RGEDF Chemical Works of Richter Gedeon PLC (PK)

BUDAPEST--Hungarian drug maker Richter Gedeon Nyrt. (RICHTER.BU) said Monday that the European Medicines Agency had accepted Richter's regulatory submission for the proposed biosimilar to Eli Lilly & Co.'s (LLY) osteoporosis treatment medication Forteo--or teriparatide.

MAIN FACTS:

- The biosimilar teriparatide has been developed by Richter-Helm BioTec GmbH & Co. KG. According to the relevant license agreements, biosimilar teriparatide is expected to be launched under both Richter and STADA labels in geographical Europe following the patent expiry of the original product.

- Richter is seeking approval for the same indications as the reference product. Teriparatide is a prescription-only medicine used for the treatment of osteoporosis, which is a leading cause of frequent bone fractures.

- A biosimilar medicine is a biological medicine, containing mostly protein as its active ingredient. It is developed to be highly similar to an already authorized biological medicine--or the reference medicine. Biosimilar medicines do not have any significant differences from the reference medicine in terms of quality, safety or efficacy.

- Teriparatide is identical to the biologically active fragment of the human parathyroid hormone, it replaces the natural hormone and stimulates bone formation. Teriparatide is used for the treatment of osteoporosis as it reduces the risk of bone fracture in various patient groups. Osteoporosis is more common in women after the menopause, and it can also occur in both men and women as a side effect of glucocorticoid treatment.

Write to Margit Feher at margit.feher@wsj.com

(END) Dow Jones Newswires

January 04, 2016 03:41 ET (08:41 GMT)

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