The US Food and Drug Administration (FDA) has approved Mylan’s Fulphila (pegfilgrastim-jmdb) – co-developed with India-headquartered Biocon – to reduce the risk of infection in nonmyeloid cancer patients following chemotherapy. The biosimilar’s successful approval is Mylan and Biocon’s second after Ogivri, a biosimilar to Roche’s Herceptin (trastuzumab), which was authorised for sale in the US late last year​. The Mylan/Biocon partnership was formed to develop and commercialise six biosimilar products. According to the collaboration agreement, Biocon is responsible for manufacturing the products at its facilities in Bangalore, India. “It is a proud moment for both Biocon and Mylan to receive this second biosimilar approval in the US,” ​a Biocon spokesperson told us. “It will enable us to pursue our path of making a difference to patient lives by providing access to high quality, more affordable biosimilars,” ​the spokesperson added. However, Fulphila’s US approval was not without regulatory setbacks. In October last year​, we reported the FDA had rejected the Neulasta candidate in response to CMC data issues observed at Biocon’s plant. Earlier this week, a Mylan representative told us that Fulphila – expected to launch in the “coming weeks”​ – is awaiting regulatory review in other geographic locations: “Mylan has submissions pending in the European Union and several additional markets including Canada, Australia and several emerging markets.”​ Development competition​ A number of companies have invested in Neulasta biosimilar programmes over the past three years, but, with the exception of Mylan and Biocon, are yet to receive regulatory approval. In July 2016​, Sandoz, a Novartis company, received an FDA complete response letter (CRL) for its Neulasta biosimilar candidate and withdrew its EU-based Neulasta biosimilar application in early 2017​. In June 2017​, the FDA vetoed Coherus’ biologics license application (BLA) for CHS-1701 – also a Neulasta biosimilar candidate – and earlier this year​, Pfenex said it was actively looking for partners to reinitiate its Neulasta biosimilar programme.<doc-sep>Mylan N.V. and Biocon announced on Tuesday that the U.S. Food and Drug Administration has approved Mylan’s Fulphila, a biosimilar to Neulasta, co-developed with Biocon to treat low count of neutrophils in patients undergoing chemotherapy in certain types of cancer. A suite of patient services also will be available after the introduction of the medicine to further support patients and caregivers with treatment, according to a BSE filing. Neulasta had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA, a clinical research firm. Biosimilar medicines are deemed by the USFDA to be highly similar to an already-approved biologic product. They fill an urgent and unmet need for more affordable alternatives to biologic therapies, increasing access and providing savings for patients and the overall healthcare system. It is projected that biosimilars will generate a savings of $54 billion in direct spending on biologic drugs in the U.S. between 2017 and 2026, according to the filing.<doc-sep>live bse live nse live Volume Todays L/H More × Biocon and its partner Mylan on Tuesday said they had got USFDA approval for Fulphila or Pegfilgrastim. Pegfilgrastim is a biosimilar version of Amgen’s Neulasta used to stimulate the level of neutrophils, a type of white blood cell that gets damaged in cancer patients undergoing chemotherapy. Neulasta had US sales of USD 4.2 billion for the 12 months ending March 31, 2018, according to IQVIA. Biocon-Mylan's Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon's joint portfolio approved in the US. The duo got the approval of breast cancer drug Trastuzumab last year. Biocon said its partner Mylan anticipates launch of Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. Also read: Biocon hits 52-week high as biosimilar for cancer drug Pegfilgrastim gets USFDA nod "It's a moment of great pride to be the first to receive approval for a biosimilar pegfilgrastim by the USFDA," said Arun Chandavarkar, Biocon CEO and Joint Managing Director. "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," Chandavarkar added. Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Neulasta is one of 11 biologic and insulin products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world. While Biocon develops and manufactures the drug, Mylan takes care of regulatory approvals and marketing. Moneycontrol had earlier reported that US FDA found purely procedural observations in its product approval inspection (PAI) of the Bengaluru facility. Also read: Biocon tumbles 4% on 7 USFDA observations for Bengaluru facility 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. Shares of Biocon rose 10 percent in the pre-opening trade on BSE on Tuesday. Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product (known as a reference product) and has no clinically meaningful differences in terms of safety and effectiveness from it. Also read: Set for FY19 biosimilar launches, Biocon says it will address observations by US, Europe regulators Biosimilar medicines are deemed by FDA to be highly similar to an already-approved biologic product. They fill an urgent and unmet need for more affordable alternatives to biologic therapies, increasing access and providing savings for patients and the overall healthcare system. It is projected that biosimilars will generate savings of USD 54 billion in direct spending on biologic drugs in the US between 2017 and 2026.<doc-sep>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.<doc-sep>
Biocon share price rallied over 6 per cent to hit its lifetime high after the pharma major and its global partner Mylan received USFDA nod for a biosimilar of a drug used to treat cancer. The stock gained as much as 6.25 per cent to its all-time high of Rs 695 on the BSE. "The US Food and Drug Administration (FDA) has approved Mylan’s 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," said Biocon in a filing to BSE. Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the US Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment. "It’s a moment of great pride to be the first to receive approval for a biosimilar pegfilgrastim by the USFDA. This important milestone comes soon after our achievement of being the first to receive USFDA approval for biosimilar trastuzumab," said Arun Chandavarkar, CEO & Joint Managing Director, Biocon. WATCH ZEE BUSINESS VIDEO HERE "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," Chandavarkar added. Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products.