European Medicines Agency Starts Valuation of Richter's Teriparatide
04 Janeiro 2016 - 6:56AM
Dow Jones News
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)
Copyright (c) 2016 Dow Jones & Company, Inc.
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