Affordable Care Act, Biosimilars

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

Viatris Receives FDA Approval for First Interchangeable Biosimilar

Wilson Sonsini Goodrich & Rosati on 8/4/2021

On July 28, 2021, the U.S. Food and Drug Administration (FDA) announced a landmark approval of Viatris Inc.’s Semglee® as the first interchangeable biosimilar product. Semglee® (insulin glargine-yfgn), indicated to control...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

ACA Strike-Down: Salvaging the BPCIA via Severability

Foley & Lardner LLP on 1/3/2019

Justice Reed O’Connor’s recent decision, Texas et al. v. U.S. et al., No. 4:18-cv-00167-O (E.D. Tex. Dec. 14, 2018), to strike down the entire Patient Protection and Affordable Care Act, 42 U.S.C. § 18001 et seq. (2010) (the...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

Is the Affordable Care Act a House of Cards? If Yes, What Does the Recent Texas Court Decision Mean for the US Health Insurance...

Epstein Becker & Green on 12/19/2018

In an unexpectedly broad ruling issued December 14, 2018, the U.S. District Court for the Northern District of Texas declared the Affordable Care Act (“ACA”) as unconstitutional in its entirety. This decision, if ultimately...more

Healthcare Law Update: May 2018

Holland & Knight LLP on 5/30/2018

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Recent Regulatory Developments in US Biosimilars Market

Foley Hoag LLP on 5/2/2018

While the Biologics Price Competition and Innovation Act (BPCI) was originally enacted under the Obama Administration as part of the Affordable Care Act, it appears that the Trump Administration will continue to take steps to...more

Health Care Weekly Preview from ML Strategies – March 2018 #3

Mintz - Health Care Viewpoints on 3/21/2018

This is the week. Congress needs to fund the government by Friday to avoid a government shutdown. It’s all but certain that the government will be funded, despite the dysfunction on display in getting through this week. The...more

Trump Administration Fiscal Year (FY) 2019 Budget and Healthcare Programs

Holland & Knight LLP on 2/19/2018

The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more

Capitol Hill Healthcare Update

BakerHostetler on 5/19/2017

Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after...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

Washington Healthcare Update

McGuireWoods LLP on 7/19/2016

This Week: Double Issue — Congress leaves for seven weeks, Congress sends opioid legislation to the President…More co-ops fail…The Supreme Court rules on Texas Abortion Case and Washington state Pharmacists and Religious...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

Washington Healthcare Update

McGuireWoods LLP on 4/12/2016

This Week: MedPAC votes on changes in Part D... Senate HELP Committee reports five “Cures” bills... One report shows uninsured number decreasing... Another says, but we still need the safety net. ...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

A&B Healthcare Week in Review

Alston & Bird on 4/1/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more

A&B Healthcare Week in Review

Alston & Bird on 3/18/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

Washington Healthcare Update

McGuireWoods LLP on 3/8/2016

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...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

A&B Healthcare Week in Review, November 2015

Alston & Bird on 11/25/2015

I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

Patient Protection and Affordable Care Act (PPACA) › Biosimilars

"My best business intelligence, in one easy email…"