Mylan-Biocon combine get USFDA nod for biosimilar pegfilgrastim

The Mylan-Biocon combine have notched up their second biosimilar in the US following the regulatory approval given to Fulphila, Mylan's biosimilar version of pegfilgrastim, originally sold by Amgen under the brandname Neulasta.

Mylan pipped other competitors in the race for this drug in the US market, when it received the US Food and Drug Administration's approval for Fulphila, a biosimilar it co-developed with Biocon. The product is used to treat fever and other signs of infection in patients treated with chemotherapy in certain types of cancer. Last December, the Mylan-Biocon combine had received the USFDA approval on their biosimilar version of Roche's breast cancer drug trastuzumab.

A US launch of Fulphila is being lined up, but an India timeline for the product is not yet on the radar.

Explaining the significance of the US launch, Mylan President Rajiv Malik told BusinessLine that the product would address affordability and access concerns in the market.

He, however, did not get into the pricing specifics, as they prepare to launch in the US market. Biosimilar drugs are usually pegged at lower prices than the original innovative drug.

Responding to whether Apotex's biosimilar version of pegfilgrastim that has received approval in neighbouring Canada could be close on their heels for US approvals, Mallik said that there was little “visibility” on Apotex's plans. Mylan, he said, was transparent on the progress and timelines on their product.

With more competition on the product, the market will shrink, Malik observed, adding, however, that the road ahead in garnering marketshare would be different from a generic drug (a chemically similar version of an allopathic medicine).

Biological drugs are made from living organisms and biosimilars are “highly similar” versions of these innovative products. Unlike a chemically similar generic medicine, a biosimilar product is complex, sensitive and more difficult to make. And that explains why Fulphila has one less indication compared to the original drug, says Malik.

The USFDA note said that Fulphila's common side effects included bone pain and pain in extremities. “Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products should not take Fulphila.” Serious side effects from treatment with Fulphila include rupture of the spleen, acute respiratory distress syndrome, serious allergic reactions, acute inflammation of the kidney, high level of white blood cells (leukocytosis), capillary leak syndrome and the potential for tumor growth. Fatal sickle cell crises have occurred, it added.

India plans

The biosimilar pegfilgrastim will be produced at Biocon's Bengaluru facility and all FDA related concerns on the plant are “behind us”, Malik said, adding that the FDA would not have approved the product if there were issues with the manufacturing facility.

The product had been registered in Europe, Australia and Canda, but not yet in India. There were a combination of reasons for this, he said, including the resources to be put behind a product and the competition that already exists in terms of local versions in the market.

In its statement, Biocon CEO & Joint Managing Director Arun Chandavarkar said that the approval was an “endorsement” of the Biocon-Mylan partnership’s ability to develop complex molecules to exacting quality and regulatory standards.

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