On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more
7/24/2025
/ Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements ,
Research and Development
With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close...more
FDA approves Omylco® (omalizumab), first biosimilar of Xolair®.
After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....more
The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more
2/19/2025
/ Biologics ,
Biosimilars ,
BPCIA ,
Clinical Trials ,
Competition ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Healthcare ,
Intellectual Property Protection ,
Medicare ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
1/14/2025
/ Biosimilars ,
EU ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
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Prescription Drugs ,
Regulatory Approval ,
Regulatory Requirements
Following the U.S. Supreme Court’s invalidation of a counterpart U.S. patent in the same family for lack of enablement (21-757 Amgen Inc. v. Sanofi (05/18/23) (supremecourt.gov)), the UPC has now rendered a decision on its...more
Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more
3/1/2023
/ Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Healthcare ,
Insurance Industry ,
Interchangeability ,
Marketing ,
Patients ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Proposed Legislation ,
USPTO
On August 2, 2022, Coherus BioSciences announced that the U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all...more
FDA and EMA both approve additional biosimilar versions of Humira® (adalimumab).
FDA also approves its third biosimilar version of Neupogen® (filgrastim). ...more
FDA and EMA both approve first biosimilar version of Lucentis® (ranbizumab).
FDA has approved only two biosimilars in 2021 after only approving three in 2020.
EMA approves four more Avastin® (bevacizumab) biosimilars,...more
On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira®...more
- FDA has not approved any biosimilars in 2021 after only approving three in 2020.
- EMA approves second Novolog® (insulin aspartate), fifth Avastin® (bevacizumab), eighth Neulasta® (pegfilgrastim), and twelfth Humira®...more
• FDA has only approved two biosimilars in 2020.
• No biosimilars have launched in the U.S. since April 2020.
• EMA approves first Novolog® (insulin aspartate), third and fourth Avastin® (bevacizumab), and sixth Herceptin®...more