Biocon - Mylan's biosimilar cancer drug `Fulphilia' gets US FDA approval

Biocon Ltd and partner Mylan NV on Tuesday announced the grant of approval by the US Food and Drug Administration (FDA) for their cancer drug Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon.

Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.
Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the US, which Mylan hopes to launch in the coming weeks.
Fulphila represents the first alternative, more affordable treatment option to Neulasta for oncology patients, the companies said in a statement, adding that a suite of patient services also will be available at launch to further support patients and caregivers with treatment.
"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. As a leading supplier of cancer medicines in the US, Mylan is committed to offering affordable and accessible solutions for patients with cancer at every step of their journey," Mylan CEO Heather Bresch said.
“Today’s approval of Fulphila represents a meaningful step forward in the affordability and accessibility of cancer care in the US... We’re pleased to reach this important milestone in partnership with Biocon and proud of the progress of our biosimilars program. We look forward to launching Fulphila and continuing to increase access to more affordable treatments,” Mylan President Rajiv Malik added.
As a global leader in the development and manufacturing of complex products, Mylan has a portfolio of 20 biosimilar and insulin analog products – one of the industry’s largest and most diverse portfolios – and deep experience with more than 60 marketing authorizations for biosimilar products worldwide.
Mylan was the first company to receive FDA approval of `Ogivri’, a biosimilar to Herceptin (trastuzumab), in late 2017 and has continued to obtain regulatory approvals for biosimilar trastuzumab in nearly 30 additional countries around the world.
“This important milestone comes soon after our achievement of being the first to receive USFDA 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,” Biocon CEO and joint managing director, Dr Arun Chandavarkar, said.
The approval for Fulphila was based on a comprehensive package of analytical, non-clinical and clinical data, which confirmed that the product is highly similar to Neulasta. The data demonstrated that there were no clinically meaningful differences between the biosimilar product and Neulasta in terms of safety, purity and potency.
Neulasta had US sales of $4.2 billion for the 12 months ending 31 March 2018, according to IQVIA.
Fulphila is not indicated for the mobilisation of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Fulphila should not be administered to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
Side effects may include splenic rupture and sickle cell crisis, including fatal cases, following the administration of Fulphila. It is advised to discontinue Fulphila in patients with acute respiratory distress syndrome and consider dose reduction or interruption in patients with glomerulonephritis. The most common adverse reactions are bone pain and pain in extremity, Biocon said.
The drug will be produced at Biocon’s Bengaluru plant, as it had received a Form 483 from the US FDA with seven observations in May. The approval indicates that Biocon’s response to the observations were satisfactory and the plant has been cleared for future exports.
Biocon is awaiting US FDA Establishment Inspection Report post the May 2018 inspection as the observations were very minor and now it has already approved the product.
The stock of Biocon has doubled in the last 12 months, compared to a 12 per cent rise in the S&P BSE Sensex.