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On June 20, FDA issued a draft guidance proposing to remove switching studies from the interchangeable biosimilar approval process.
The draft guidance eliminates the longstanding recommendation that biosimilar developers provide clinical data showing interchangeability with reference drug...

According to a recent Draft Guidance, FDA is considering eliminating written requests for pediatric exclusivity under the Best Pharmaceuticals for Children Act (BPCA) when the studies are already required under the Pediatric Research Equity Act (PREA).
If finalized, the Guidance would remove...

Growth in orphan drug sales is surpassing growth in the broader pharmaceuticals market. Analysts estimate that top-selling orphan drugs like Darzalex and Ultomiris will make up 20% of all prescription drug sales by 2026. With sales hitting $160.5 billion in 2021, estimates predict that the orphan...

On August 5, 2021, a Federal Circuit panel upheld a $235 million verdict against Teva Pharmaceuticals over induced infringement of GlaxoSmithKline's Coreg (carvedilol).
The precedent setting decision has generic applicants questioning what exactly constitutes induced infringement regarding...

On August 13, 2021, FDA announced it would accept comments on a proposal to treat pre-Hatch-Waxman abbreviated new drug applications, or PANDAs, as NDAs. Despite objections, the agency is apparently already implementing changes.
With the 1984 Hatch-Waxman Amendments, generic drugs are...

On March 31, the Federal District Court in Maryland upheld the Centers for Medicare & Medicaid Services’ (CMS) “new formulation” definition. CMS issued the new definition in its November 2021 final rule under the Medicaid Drug Rebate Program (MDRP), taking effect January 1,...

Over the past few years, FDA has lobbied to tighten (or even eliminate) the 180-day exclusivity period currently granted to the first generic drug applicant that submits an ANDA seeking FDA approval for a generic based on a listed drug product.
This exclusivity period provides an incentive...

On September 30, 2021, a Washington D.C. circuit appellate court ruled that FDA violated the Orphan Drug Act and unlawfully infringed on Catalyst Pharmaceuticals Inc.’s orphan drug exclusivity period when it approved another company’s drug - the same drug to be used in treating the same...

From Humira and Rituxan to Herceptin and Enbrel, biologics continue to succeed in tackling numerous, challenging diseases and conditions. Many new biologics receive Orphan Drug designation for treating rare diseases, meaning sponsors get 12 years of Reference Product Exclusivity and seven years of...

On December 27, 2020, FDA extended the Rare Pediatric Disease Priority Review Voucher Program as part of the Coronavirus Response and Relief Supplemental Consolidated Appropriations Act of 2021.
Originally set to expire in October 2020, renewal of the Rare Pediatric Disease Priority Review...