The partnership says that it will launch the drug in the European Union on or after October 16, 2018.
Today, Mylan and its partner Fujifilm Kyowa Kirin Biologics announced that the European Commission has granted marketing authorization to Hulio, the partnerships’ adalimumab biosimilar referencing Humira. The biosimilar received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the molecule, FKB327, in July 2018.
The authorization applies to all 28 EU member states, as well as the European Economic Area states, for all indications of the reference Humira.
Mylan President Rajiv Malik commented, “We’re very pleased with the decision of the European Commission to grant marketing authorization for Hulio. This is the fourth product that Mylan will be bringing to market in the area of complex generics and biosimilars, and we’re proud to be a leader in the market formation. We’ve made great progress with Fujifilm Kyowa Kirin Biologics and look forward to continuing this important collaboration.”
The partnership says that it will launch the drug on or after October 16, 2018; in a statement, the companies revealed that Fujifilm Kyowa Kirin has obtained a nonexclusive royalty license with Humira maker, AbbVie, for the use and sale of adalimumab in Europe, and that Mylan has a sublicense. Mylan has previously announced a settlement with AbbVie that covered only Mylan’s right to market a biosimilar adalimumab in ex-European territories, including the United States, starting in July 2023.
Hulio will join a widening group of adalimumab biosimilars entering the European marketplace next month; Samsung Bioepis and Biogen stuck a deal with AbbVie in April 2018 that will allow them to launch their Imraldi on October 16, and Amgen reached a similar settlement in 2017 that will allow it to enter the market on the same date as Imraldi.
Health systems in Europe are already preparing to introduce biosimilar adalimumab and reap what they hope will be a substantial cost savings; the United Kingdom’s National Health Service, for one, has implemented a working group to provide oversight on using the best-value adalimumab using a commissioning framework that launched in 2017. The framework proposes that at least 90% of patients new to treatment and 80% of patients currently receiving treatment be prescribed the best-value biologic within 12 months of the launch of a biosimilar for a given biologic therapy.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
2 Commerce Drive
Cranbury, NJ 08512