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Biologics

Venable LLP

Biden FY25 HHS Budget Eliminates the Separate Interchangeability Designation for Biosimilars

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On March 11, 2024, the White House released President Biden’s FY 2025 Department of Health and Human Services (HHS) Budget in Brief, which outlines $130.7 billion in discretionary funding for HHS. ...more

Mayer Brown

BioUtah Podcast with Vera Nackovic

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Join BioUtah president & CEO Kelvyn Cullimore and Mayer Brown’s Vera Nackovic in a discussion about current trends and issues in the life sciences industry....more

Alston & Bird

Health Care Week in Review: Congress Passed a New Continuing Resolution for FY 2024 to Avert a Government Shutdown; Biden...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

FDA Approves XOLAIR to Treat Children and Adults With One or More Food Allergies

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​​​​​​​Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental...more

Goodwin

FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

Goodwin on

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed information about...more

Morgan Lewis - As Prescribed

Key Issues for Life Science Executives for 2024: JP Morgan Healthcare Conference Takeaways

It is hard to believe that we are already in February and it has been a month since the 42nd Annual JP Morgan Healthcare Conference in San Francisco wrapped. It was a packed four days in which the major players in the life...more

Alston & Bird

Health Care Week in Review: HRSA Issues Requests For Proposals As Part Of Initiative To Reform The Organ Transplant System;...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

Biosimilar Regulatory Updates - February 2024

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On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. CT-P47 references Genentech’s ACTEMRA, an interleukin 6 receptor...more

Venable LLP

Celltrion Submits an aBLA for Actemra® (tocilizumab) Proposed Biosimilar CT-P47

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On January 28, 2024 Celltrion announced the submission to the FDA of an aBLA for CT-P47, a proposed biosimilar of Genentech’s Actemra® (tocilizumab). This is the third publicly announced aBLA filing for an...more

Morgan Lewis

Blockbuster Biologics Review - Issue 22

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Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more

Fish & Richardson

Webinar | Biosimilars 2023 Year in Review

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Since the passage of the Biologics Price Competition and Innovation Act, the field of biosimilars has expanded and evolved. Keeping abreast of these changes helps stakeholders understand future opportunities. On January 30,...more

Goodwin

Year in Review: Top Regulatory Developments of 2023

Goodwin on

​​​​​​​As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023....more

Venable LLP

Accord’s aBLA for Proposed Biosimilar DMB-3115 Accepted by FDA

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According to a January 2024 press release from Accord BioPharma, Inc. (“Accord”), the FDA accepted Accord’s abbreviated Biologics License Application (aBLA) for DMB-3115 (ustekinumab), a proposed biosimilar to Janssen...more

Goodwin

Year in Review: Top Legal Developments of 2023

Goodwin on

​​​​​​​As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more

Morgan Lewis - As Prescribed

Pharma’s Almanac: Forecast at the Turn of the Year

The ball has dropped on the healthcare and life sciences industry’s unique New Year tradition, the J.P. Morgan Healthcare Conference, so all eyes turn to 2024. To help define a path forward, Morgan Lewis FDA and healthcare...more

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

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On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

Morgan Lewis

2023 Drugs and Biologics Year in Review: Will FDA's 2023 Evolution Usher in Swift Resolutions for 2024?

Morgan Lewis on

The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and...more

Hogan Lovells

JPM2024: Investing in preemptive medicine programs

Hogan Lovells on

An already challenging financing market can seem especially daunting for innovative technologies that seek to go beyond merely treating a disease in order to promote healthy longevity. Innovators inspired by the promise of...more

Hogan Lovells

JPM2024: What to expect from FDA in an election year

Hogan Lovells on

Despite continued perceived economic headwinds, cutting edge research continues to provide new opportunities for life saving therapies for patients. However, early development programs for advanced medicines using innovative...more

Goodwin

Year in Review: Top Deals in 2023

Goodwin on

According to PWC, “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a recap of the top M&A deals in 2023 that...more

Goodwin

Biosimilar Deals Updates: Biocon, AstraZeneca

Goodwin on

As an update to our previous report, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced the successful completion of the transition of the acquired biosimilars business in approximately 120 countries, a year ahead...more

Goodwin

Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

Goodwin on

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents....more

Venable LLP

Celltrion Completes Application for FDA Approval of CT-P41, Biosimilar of Prolia® / Xgeva®

Venable LLP on

On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab)...more

Venable LLP

EYLEA® (aflibercept) IPR and BPCIA Litigation Updates

Venable LLP on

There has been a flurry of activity relating to proposed EYLEA® (aflibercept) biosimilars in November, starting with a BPCIA litigation against Celltrion’s proposed biosimilar CT-P42 filed on November 8, 2023, Case No....more

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Privacy Officer
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150 Harbor Drive, #2760
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