Score one for biosimilars after Novartis breaks into Japan (NVS, AZN, DNA, AMGN, GENZ, GILD, CELG)
Novartis AG (NYSE: NVS) shares will be among the health care names to watch Thursday after Japan approved one of the company’s human growth hormones, the first approval in Japan of a generic biotech drug.
Japan regulators approved the Novartis generic of Somatropin to treat growth hormone deficiency in children and growth disturbance associated with Turner’s syndrome. It’s most similar to Pfizer Inc’s (NYSE: PFE) brand-name drug Genotropin.
The announcement is a score for high-end generic drug companies that are seeking to expand the reach of biosimilars, or generic biotech drugs. The drugs made from living cells are more expensive to duplicate than traditional medicines designed from chemical compounds.
Few companies are capable of making biosimilars today, and Novartis is one of the few. Another is AstraZeneca plc (NYSE: AZN), which recently began targeting the market.
Brand-name biotech drug makers such as Amgen Inc. (Nasdaq: AMGN), Genentech Inc. (NYSE: DNA) and Genzyme Corp (Nasdaq: GENZ), Gilead Sciences Inc. (Nasdaq: GILD) and Celgene Corp. (Nasdaq: CELG) are fighting against biosimilars to protect exclusivity for their products.
But federal legislation was proposed back in March that seeks to define the length of time brand-name biotech drugs would have market exclusivity. Shortening that timeframe and promoting biosimilars is part of President Obama’s health care strategy.
. — Mike Tarsala.
