A recent announcement came forward from Amgen Inc.(NASDAQ:AMGN). This announcement delineated the company’s decision to continue striving to stop the launch of Novartis’ first biosimilar drug in US market. Amgen Inc. (NASDAQ:AMGN) is considering filing an appeal against the court’s decision of rejecting Amgen Inc. (NASDAQ:AMGN)petition. This petition was filed so that Sandoz Inc., which is a division of Novartis AG (ADR) (NYSE:NVS) stops the very first biosimilar drug to be launched into US markets.
Amgen Inc. (NASDAQ:AMGN) has appealed against the court’s refusal to pass orders against the launch of Zarxio,developed by Sandoz Inc., which happens to be the biosimilar version of Neupogen, Amgen Inc. (NASDAQ:AMGN)has filed an appeal both against the rejection of its petition and the court’s decision which favored Sandoz Inc.
Aude Gerspacher and Asthika Goonewardene, who have been serving as analysts at Bloomberg presented a report. This report reflected the court’s decision whereby the request of both the companies for acceleration of the case was granted. Sandoz Inc.’s response is due at 31st of March, whilst Amgen Inc. (NASDAQ:AMGN) would be making its reply by the second of April. The court’s ensuing decision about Amgen Inc. (NASDAQ:AMGN)motion would probably come forward in early April.
This second petition filed by Amgen Inc. (NASDAQ:AMGN) against court’s decision in favor of Sandoz Inc. as well as its denial of the former company’s petition will cause a further delay in the release of biosimilar drugs in US. Even though, Zarxio has been approved by US Food and Drug Administration and the court has also given its decision in favor of it, still the launch of Zarxio will probably undergo a delay.
There are no legal restrictions or obstacles hindering this launch. However, SandozInc. has agreed to withhold this launch until the eleventh of May or until the court gives its decision in favor of Sandoz Inc., against the second petition filed by Amgen Inc.(NASDAQ:AMGN).
Following the manufacture of Zarxio, Sandoz Inc. had to face a petition filed against it by Amgen Inc. (NASDAQ:AMGN).The allegation placed by the latter company was primarily unfair competition along with patent infringement. This is because, Zarxio is a biosimilar version of Amgen Inc.’s(NASDAQ:AMGN) block buster drug Neupogen. Neupogen is basically deployed for the treatment of cancer patients, in order to cure Neutropenia. Another allegation placed by Amgen Inc.(NASDAQ:AMGN) on Sandoz Inc. was that it hasn’t complied with the disclosure regulations, as required by the Biologics Price Competition and Innovation Act (BPCIA).
Zarxio had been developed from the same active ingredient which makes up Neupogen. An application for the approval of this drug was filed with the US Food and Drug Administration in July 2014. This was the first biosimilar drug brought forward for approval. Previously FDA did not undertake the approval of such drugs because of the unavailability of an appropriate framework in order to establish the efficacy and safety of these drugs.
Patient Protection and Affordable Care Act 2010 gave authority to FDA and all such bodies to examine such imitation drugs and ultimately approve or disapprove them. Since these imitation drugs aren’t the exact copies, therefore their examinations also has to be very comprehensive.
