Novartis AG (ADR) To Come Up With Another Biosimilar

Novartis got approval for its second biosimilar drug with Amgen.

After igniting a lot of controversy after the launch of its biosimilar drug earlier, Novartis AG is again all set to initiate a dispute with its rival Amgen Inc. both the companies who have not been on good terms since a long time might simply collide again with the launch of Novartis’s second biosimilar drug. The company recently got its drug approved by the United States Food and Drug Administration (FDA). Enbrel, which is said to be one of the most popular cancer drugs from Amgen, has helped them gaining a stable position in the healthcare industry. However, now Novartis is all set to come up with a biosimilar, which is a replica of Enbrel. The company proudly announced on Friday that the FDA has granted a permit for the Sandoz’s regulatory filing for the drug. Biosimilars are considered as copycat drugs that have an origination from hefty priced biologics. Both the drug versions can certainly not be exact replicas since both will be using different living cells to develop the medicine. The biosimilar drugs have been present in the European health care market since fiscal year of 2006 but due to the negligible presence of a regulatory body, these drugs did not get an approval till 2010. When the Patient Protection Affordable Care Act was permitted then healthcare companies were allowed to work and progress into the biosimilar industry. However, the companies have to deal with a rigorous examination. It is said that the drug developers were also asked to initiate clinical trials so that they can [prove the similarity between the two drugs. Both the companies will now be battling over a copycat drug but despite all the lawsuits and acquisitions that NVS had to deal with earlier, they are still keen to repeat the same situation again. Zarxio is said to be the first biosimialr drug that was approved in the United States, which is developed by Novartis. This drug is said to be a replica of Neupoge, which is Amgen’s top of the rank cancer-curing drug. The drug got an approval in the month of March but after dealing with various lawsuits, the company finally launched the drug within United States healthcare sector in September. A difference was observed in the pricing of both the drugs, as Novartis retailed the drug at a dropped price of 15% from Amgen’s Neupoge. Despite a drop in price was observed but health insurers were not satisfied since they expected a 40% drop.