Mylan’s Fulphila (pegfilgrastim-jmbd), which was co-developed with Biocon, has become the first FDA-approved biosimilar of Amgen’s Neulasta (pegfilgrastim). The biosimilar will be used to treat patients undergoing chemotherapy and reduce the duration of infection and fever in those with a low neutrophil count, known as febrile neutropenia.
“I couldn’t be prouder of this approval for Fulphila, the first alternative option for pegfilgrastim approved in the US, as it represents an important milestone for patients and further demonstrates Mylan’s continued fight to expand access to medicine,” said Mylan CEO Heather Bresch. “FDA’s approval of this product, as well as the agency’s continued focus on biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients.”
Mylan expects their biosimilar version of Neulasta will be made available to patients in the next few weeks. The company has also established a number of patient services aimed at helping them gain access to this more affordable cancer drug.
“Today’s approval of Fulphila represents a meaningful step forward in the affordability and accessibility of cancer care in the US,” said Mylan President Rajiv Malik. “It also is yet another confirmation of Mylan’s deep scientific, clinical, regulatory and intellectual property capabilities, which are widely recognized in the industry and bolster Mylan’s reputation as a partner of choice in the global effort to bring complex medicines to market.”
Mylan has been on a role lately with their biosimilar version of the breast cancer drug Herceptin, named Ogivri, gaining FDA approval in late 2017. The company has since secured regulatory approval for the biosimilar in almost 30 other countries.
“The approval of Fulphila, the first biosimilar to Neulasta, joins other recent examples such as the approval of Ogivri, the first biosimilar to Herceptin, in the growing portfolio of complex medicines that Mylan is making available for patients who need them,” said Malik. “We’re pleased to reach this important milestone in partnership with Biocon and proud of the progress of our biosimilars program.”
According to health data science company IQVIA, Neulasta brought in sales to the tune of $4.2 billion in the US from March 2017 to the same month in 2018. By offering a less-expensive biosimilar version of Amgen’s Neulasta, Mylan is hoping to capture a portion of this lucrative market.
“It’s a moment of great pride to be the first to receive approval for a biosimilar pegfilgrastim by the [FDA],” said Biocon CEO & Joint Managing Director, Dr. Arun Chandavarkar. “This important milestone comes soon after our achievement of being the first to receive [FDA] approval for biosimilar trastuzumab. It represents a further endorsement of the Biocon-Mylan partnership’s ability to successfully develop complex molecules to exacting quality and regulatory standards. This approval expands our oncology portfolio for the benefit of cancer patients and supports our mission to improve access to high quality, affordable biopharmaceuticals globally.”
In all, Mylan currently has 20 biosimilars in their drug development pipeline, including insulin analogue products. The company also holds over 60 marketing authorizations for their biosimilar drugs in numerous countries around the world.