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
Targeted protein degradation (TPD) is transforming drug discovery by leveraging the cell’s natural protein disposal systems to eliminate disease-causing proteins. Innovators are making rapid and successful advancements in the...more
On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed a five-year patent term extension (“PTE”) for Merck’s sugammadex patent, holding that the district court had correctly calculated PTE based on the...more
3/20/2025
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Patent Litigation ,
Patent Reissue Applications ,
Patent Term Extensions ,
Patent Terms ,
Patents ,
Pharmaceutical Industry ,
USPTO
In our previous articles, we reported that the Federal Circuit affirmed the district court’s decision on December 20, 2024 ordering Teva Pharmaceuticals (“Teva”) to delist certain patents related to Teva’s ProAir® HFA...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 ,
Popular ,
Prescription Drugs ,
Regulatory Approval ,
Regulatory Requirements
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more
12/23/2024
/ Abbreviated New Drug Application (ANDA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Listing Rules ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Statutory Interpretation ,
Teva Pharmaceuticals
In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more
Gene therapy is part of a new wave of medicine that approaches disease treatment by addressing the root causes rather than focusing on treating or reducing symptoms. Currently, gene therapies are being developed for treatment...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
Cadent Therapeutics, a Cambridge, Massachusetts-based, privately held clinical stage biopharmaceutical company focused on the development of therapies for the treatment of cognitive, mood, and movement disorders, announced on...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