Viswanath Pilla Moneycontrol News
Bio-pharmaceutical firm Biocon said the latest verdict by US Supreme Court in the case of Amgen versus Sandoz will help biosimilar makers expedite the launch of the lifesaving drugs without waiting an additional six months after exclusivity period ends.
"We are pleased with the US Supreme Court decision as it clarifies that the Biologics Price Competition and Innovation Act (BPCIA) was intended to facilitate the entry of biosimilar drugs into the market and not grant an additional six months of exclusivity to innovators,” said Kiran Mazumdar-Shaw, CMD of Biocon in an e-mail interaction with Moneycontrol.
“The Court’s ruling opens the possibility for patients gaining quicker access to new and potentially lifesaving biosimilars,” Mazumdar-Shaw said.
Two of the Biocon’s biosimilars pegfilgrastim and trastuzumab are now under review by the US drug regulator, while the company is in the process of filing biologics license application (BLA) in US for insulin glargine shortly.
Pegfilgrastim is used to stimulate the level of neutrophils, a type of white blood cell, in cancer patients undergoing chemotherapy; trastuzumab is used in the treatment of HER2-positive metastatic breast cancer.
Biocon, which has been spending heavily on research and development for years, has the first-mover advantage and is much ahead over other Indian drug makers when it comes biosimilars.
The company is expecting to roll out its first ever biosimilar in US market in FY19.
The latest judgement can speed-up that process.
“By reducing the uncertainty around the introduction of biosimilars in the US, this development augurs well for the continued expansion of the US biosimilars market,” Mazumdar-Shaw added.
The US Supreme Court in a unanimous judgment ruled in favour of Sandoz, the generic unit of Swiss pharmaceutical major Novartis – overturning an earlier court's ruling.
In 2015, the US Court of Appeals for the Federal Circuit ruled that biosimilar developers must give the 180-day notice after FDA approval.
California-based biotech company Amgen sued Sandoz in 2014 in US District Court in San Francisco, alleging that the Novartis unit infringed its patent for Neupogen (filgrastim) and violated the Affordable Care Act provision governing biosimilars.
Amgen contended that Sandoz and other biosimilar developers had to wait 180 days from FDA licensure before launching biosimilar drugs even after getting an approval by the US FDA as per the provision under the Biologics Price Competition and Innovation Act (BPCIA).
The BPCIA requires biosimilar drug developers to give reference drug makers 180 days’ notice that they will launch a biosimilar version. The 180 days provision gives six extra months of exclusivity over and above the 12-year exclusivity granted to reference drug developers under the BPCIA, severely impacting the access of biosimilar drugs to patients and also millions of dollars’ worth savings for exchequers.
Biosimilars are identical copies of original biologic drugs that have active properties similar to the reference biological product requiring large clinical trials on patients to establish safety and efficacy before approval by regulatory agencies, unlike small generic molecules that can be launched by doing bioequivalence studies.
Biosimilars are said to be cheaper by 30-40 percent over innovator biologic drugs.
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