It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more
9/13/2021
/ Biden Administration ,
Biosimilars Action Plan (BAP) ,
BPCIA ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid Drug Rebate Program ,
Medicare Part B ,
Medicare Part D ,
MedPAC ,
Pharmaceutical Industry ,
Prescription Drugs
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more
12/17/2019
/ Biosimilars ,
Biosimilars Action Plan (BAP) ,
Biotechnology ,
BPCIA ,
Clinical Trials ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigational New Drug Application (IND) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Service Act ,
Regenerative Medicine ,
Regulatory Agenda ,
Regulatory Standards ,
Stem cells
On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate that a proposed biosimilar product meets the statutory interchangeability...more
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....more
As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more
12/19/2017
/ 21st Century Cures Act ,
Abbreviated New Drug Application (ANDA) ,
aBLA ,
Biologics ,
Biosimilars ,
BPCIA ,
FDA Approval ,
FDARA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment
On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more
6/16/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
FDA Approval ,
Generic Drugs ,
IP License ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Pharmaceutical Patents ,
Pharmacies ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims
Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new...more
In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of...more
On February 9, 2016, the FDA’s Arthritis Advisory Committee voted 21-3 to recommend that CT-P13, Celltrion’s proposed biosimilar of Janssen Biotech, Inc.’s Remicade® (infliximab) be approved for all indications — including,...more
Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on...more
12/15/2015
/ Amarin ,
Biosimilars ,
BPCIA ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Off-Label Promotion ,
Personalized Medicine ,
Precision Medicine Initiative (PMI) ,
Preliminary Injunctions ,
Stem cells ,
Telemedicine
On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and...more
On the heels of its approval of the first biosimilar product in March, FDA has just released final versions of three key biosimilar guidance documents under the Biologics Price Competition and Innovation Act (BPCIA). The...more