Affordable Care Act, BPCIA

FDA Biosimilar Approval Recap – 2021

McDonnell Boehnen Hulbert & Berghoff LLP on 1/6/2022

The U.S. Food and Drug Administration approved four biosimilar drugs in 2021 under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act...more

FDA Approves Another Interchangeable Biosimilar Drug

McDonnell Boehnen Hulbert & Berghoff LLP on 10/22/2021

On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug. That drug is Cyltezo (adalimumab-adbm), produced by Boehringer Ingelheim, which obtained biosimilar approval on August...more

BPCIA Survives Challenge to the Affordable Care Act at Supreme Court

Kramer Levin Naftalis & Frankel LLP on 6/17/2021

On June 17, 2021, the Supreme Court of the United States issued its decision in California et al. v. Texas et al. (No. 19-840), upholding the Affordable Care Act (ACA). A bloc of U.S. states, led by Texas, and two individuals...more

Healthcare, Biologics, and Severability: Will the ACA—and the BPCIA—Survive the Latest Challenge?

Morrison & Foerster LLP - Federal Circuitry on 11/18/2020

The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) is looking alive and well after last week’s Supreme Court oral argument on the Affordable Care Act (“ACA”). If you didn’t realize the BPCIA was at issue...more

Future of Biosimilars at Issue in Latest Supreme Court Affordable Care Act Case

Patterson Belknap Webb & Tyler LLP on 11/16/2020

On Tuesday, November 10, 2020, the Supreme Court heard oral argument in California v. Texas, a challenge to the Affordable Care Act (the “ACA”) brought by Republican Attorneys General and the Trump Administration. ...more

Trump administration reversal would take away FDA’s authority to approve biosimilars

Hogan Lovells on 7/15/2020

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Legal Developments to Keep an Eye Out for in 2020

Goodwin on 1/6/2020

Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s...more

Year in Review: Top Five Biosimilar Legal Developments of 2018

Goodwin on 12/31/2018

Here are our picks for the top five most significant legal developments of 2018 that may impact the biosimilar industry: 1. New Law Requiring FTC/DOJ Review Of Biosimilar Patent Litigation Settlements - With the...more

Federal District Court in Texas Rules that Entire ACA is Invalid

Goodwin on 12/18/2018

As has been widely reported over the past few days, the federal district court for the Northern District of Texas has issued an order declaring that the individual mandate of the Affordable Care Act (ACA, commonly referred to...more

100 Days Plus Under Trump: What They Mean for Biologics

Patterson Belknap Webb & Tyler LLP on 5/15/2017

President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more

Republican Healthcare Bill Would Leave BPCIA Untouched

Patterson Belknap Webb & Tyler LLP on 3/9/2017

In public debates over the Affordable Care Act (ACA), also known as Obamacare, biosimilars are rarely, if ever, mentioned. But the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA), was in...more

BPCIA Appears Unaffected by Proposed New Healthcare Law

Goodwin on 3/8/2017

On Monday, March 6, House Republicans unveiled their plan to repeal and replace the Affordable Care Act (“ACA”). Although the proposed legislation repeals or amends several provisions of the ACA, based on a preliminary...more

Basics of the BPCIA

Womble Bond Dickinson on 11/21/2016

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Will President-Elect Trump and the Republican-Led Congress Repeal the BPCIA?

Goodwin on 11/18/2016

As we have previously reported, Donald Trump’s election to the presidency and the maintenance of majorities by the Republican Party in both the U.S. Senate and House of Representatives have led to questions about the fate of...more

U.S. Biosimilars Pathway Under Trump

Patterson Belknap Webb & Tyler LLP on 11/14/2016

This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception. Two of Trump’s stated policies...more

Will Trump’s Election Impact the BPCIA?

Goodwin on 11/9/2016

The election last night of Donald Trump as the next President of the United States may have far-reaching consequences on numerous legal and policy issues, including immigration, international trade, and health care. Although...more

6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit

Mintz - Health Care Viewpoints on 7/6/2016

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

FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar

Snell & Wilmer on 4/8/2016

The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar – Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer...more

FDA Releases Naming Guidance

McDonnell Boehnen Hulbert & Berghoff LLP on 4/7/2016

The Biologic Price Control and Innovation Act (BPCIA), enacted as part of President Obama's Affordable Care Act (better known as "Obamacare," Public Law 111-148), provided for the first time in the U.S. a path for FDA...more

Health Care Update - February 2016 #2

Mintz - ML Strategies on 2/16/2016

Martin Shkreli Not the Big Story on the Hill Last Week - Congress’s complex relationship with prescription drugs was on display last week in the House of Representatives. In the House Committee on Oversight and...more

Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute

Polsinelli on 4/1/2015

The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more

Biosimilars Webinar - July 23, 2013

Knobbe Martens on 7/26/2013

On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop...more

Patient Protection and Affordable Care Act (PPACA) › BPCIA

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