- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Merck Terminates Follow-on Insulin Agreement with Samsung Bioepis
According to a filing made in the Republic of Korea, Samsung Bioepis has disclosed that Merck has terminated the companies' development and commercialization agreement for a follow-on insulin glargine product referencing Sanofi’s Lantus.
According to a filing made in the Republic of Korea, Samsung Bioepis has disclosed that Merck has terminated the companies' development and commercialization agreement for a follow-on insulin glargine product referencing Sanofi’s Lantus.
Despite tentative FDA approval received in July 2017, Merck and Samsung have faced significant challenges in bringing the follow-on biologic, Lusduna Nexvue, to market in the United States.
One hurdle, patent infringement litigation brought by reference product developer Sanofi, was ongoing, and triggered an automatic stay on the FDA’s final approval of up to 30 months.
Merck concluded to end the partnership after assessing the current and future market for the product, including pricing and the product’s cost, before reaching its decision. In ending the partnership, Merck paid Samsung $155 million to cover investments made thus far in the product, plus interest, reported FiercePharma. However, its partnership with Samsung on other biosimilars in oncology and immunology remain unchanged.
Drug developer Mylan, in a partnership with Biocon, is having similar troubles with its follow-on insulin referenced on Lantus. The product, which is already approved in Europe and sold under the name Semglee, is currently undergoing its own patent lawsuit from Sanofi. In the 70-page lawsuit filed in October 2017, Sanofi alleged that Mylan is infringing on 18 patents and asked a federal court in New Jersey to intervene in the launch efforts.
The lawsuit, however, is not the only challenge Mylan has faced in bringing its follow-on insulin to market, as it received a Complete Response Letter (CRL) from the FDA in June, citing production problems at the Malaysia plant responsible for producing the product.
Competing against reference Lantus in the follow-on insulin market already is Boehringer Ingelheim’s Basaglar, the first follow-on insulin glargine to earn FDA approval.
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?
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.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
