Pushing forward with his commitment to accessibility, Commissioner Gottlieb recently announced further efforts to encourage generic approval. In another FDA Voice Blog Post, Dr. Gottlieb reiterated the agency’s renewed focus on drug pricing and competition and announced new measures to aid in the development of …
Earlier this week, FDA published another in its series of guidance documents devoted to implementing the Biologics Price Competition and Innovation Act (“BPCIA”). The objective of the new guidance, entitled Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry, is to assist sponsors in demonstrating …
After this year’s unanimous Supreme Court decision in Amgen v. Sandoz was remanded to the Federal Circuit (see our previous post here), that Court is now in the midst of addressing Biologics Price Competition and Innovation Act (“BPCIA”) state law preemption. In August, the parties …
As we mentioned back in July, courts continue to address a wide variety of procedural questions arising from the Biologics Price Competition and Innovation Act (“BPCIA”). The most recent is a decision from the Federal Circuit in an interlocutory appeal pending since July 2016 in …
In the almost four years since passage of Title I of the Drug Quality Security Act, (the Compounding Quality Act), FDA has inspected hundreds of pharmacies, issued numerous Form 483s and warning letters, and has requested both voluntary recalls and cessation of non-sterile and sterile …
On July 18, 2017, FDA held a highly anticipated public meeting discussing the balance between pharmaceutical competition and innovation. Titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access,” the meeting drew a tremendous response from industry with dozens of non-FDA or FTC …
In the aftermath of the Sandoz v. Amgen Supreme Court decision, both sides should be happy that some of the procedural uncertainty surrounding the Biologics Price Competition and Innovation Act (“BPCIA”) patent dance has been resolved. But that would be too easy. Even though U.S. Supreme …
As a prelude to FDA’s Hatch-Waxman Act public meeting next month, FDA announced today an updated a Manual of Policy and Procedures (MAPP) for review of generic drug applications and a public list of off-patent and off-exclusivity NDA products without ANDA competition. Effective June 27, 2017, …
On June 21st, FDA announced an all-day public meeting dedicated to the Hatch-Waxman Amendments that will take place on July 18, 2017. The meeting, titled “The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access,” is part of Commissioner Gottlieb’s Drug Competition Action Plan, which he …
In a relatively infrequent unanimous decision, the U.S. Supreme Court this morning (June 12th) interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) such that the biosimilar patent dance is not mandatory. As regular readers of the FDA Law Blog know, Amgen sued Sandoz for …
The comment period on FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product recently closed (Docket No. FDA-2017-D-0154), and it seems like everyone has something to say about the guidance. With over 50 comments submitted, some very technical in nature, FDA has some deep …
Apotex and its subsidiary Apobiologix submitted a Citizen Petition (Docket No. FDA-2017-P-2528) on April 21, 2017 asking that FDA ensure a level playing field for all biosimilar applicants referencing NEULASTA (pegfilgrastim). A common tactic in the small molecule world to introduce additional hurdles to generic …
On April 21, FDA approved Samsung Bioepis’ Renflexis, a biosimilar referencing Pfizer’s Remicade. Like Remicade, Renflexis is approved for the treatment of Crohn’s Disease (both pediatric and adult), Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis. Remicade was approved as an Orphan …
Oh Canada! Congress has decided that it’s once again time to start looking to our neighbors to the north for some help increasing accessibility and decreasing cost of prescription drugs. With two new bills introduced in the last month, one in each chamber of Congress, …
On Friday, Amgen submitted its Opening and Response Brief at the Supreme Court in the matter of Sandoz v. Amgen, Nos. 15-1039, 15-1195. The brief addressed two major questions with respect to the BPCIA: when an applicant can provide 180-day notice of biosimilar marketing and …
