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Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2020

Goodwin on

As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020. Please keep an eye out this week for posts identifying the most important regulatory,...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Boehringer Ingelheim Seeks to Redefine a Biosimilar’s “Strength”

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics...more

Goodwin

Boehringer Ingelheim Files Citizen Petition Urging FDA to Address “Strength” Definition for Biosimilars, Citing Concerns Over...

Goodwin on

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service Act for parenteral...more

Rothwell, Figg, Ernst & Manbeck, P.C.

FDA’s New Draft Guidance Regarding Biosimilarity and Interchangeability

On November 20, 2020, the U.S. Food & Drug Administration (“FDA”) released a Q&A-format draft guidance to address four questions regarding the submission of biologics license applications (BLAs) and labeling for...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more

Patterson Belknap Webb & Tyler LLP

FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability

FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” ...more

Goodwin

New FDA Draft Guidance on Biosimilarity and Interchangeability

Goodwin on

The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” According to the FDA, the draft guidance is “intended to...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Venue Considerations for Hatch-Waxman and BPCIA Litigation

In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent...more

Morrison & Foerster LLP - Federal Circuitry

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

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

Patterson Belknap Webb & Tyler LLP

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

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

Downey Brand LLP

Proposition 65 Notices of the Month – Oct. 2020: Lead in Food, Diethanolamine in Personal Care Products, Formaldehyde in Bed Sheet...

Downey Brand LLP on

October 2020 Proposition 65 (“Prop. 65”) claims were, once again, varied and abundant with respect to food and consumer product allegations. Plaintiff groups issued three hundred and thirty-three (333) total Prop. 65 60-Day...more

Downey Brand LLP

Proposition 65 Notices of the Month – Sept. 2020: Hundreds of Notices Allege Acrylamide in Snack Foods and Phthalates in Plastic...

Downey Brand LLP on

September 2020 Proposition 65 (“Prop. 65”) claims were, for the most part, “oldies but goodies.” Plaintiff groups issued three hundred and forty (340) total Prop. 65 60-Day Notices of Violation (“Notices), over two hundred...more

Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline

• FDA has only approved two biosimilars in 2020. • No biosimilars have launched in the U.S. since April 2020. • EMA approves first Novolog® (insulin aspartate), third and fourth Avastin® (bevacizumab), and sixth Herceptin®...more

Robins Kaplan LLP

Financial Daily Dose 9.22.2020 | Top Story: Microsoft Drops $7.5B on Gaming Acquisition to Challenge Rival Sony

Robins Kaplan LLP on

Microsoft made a huge gaming move on Monday with its $7.5 billion acquisition of ZeniMax Media, the “parent company of gaming studios like Bethesda,” and maker of titles like “The Elder Scrolls, Fallout, Doom, Quake and...more

American Conference Institute (ACI)

[Virtual Event] 11th Summit on Biosimilars & Innovator Biologics - September 23rd - 24th, 7:45 am - 5:00 pm ET

This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more

Fish & Richardson

How Biosimilars Are Approved and Litigated: Patent Dance Timeline

Fish & Richardson on

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference biological product. Biosimilar applicants have a number of choices to make on the path...more

Downey Brand LLP

Proposition 65 Notices of the Month – July 2020: Notices Decline for Acrylamide in Snack Foods; Chocolate, Canned Goods, Dietary...

Downey Brand LLP on

In July, citizen plaintiff enforcers of California’s Proposition 65 (“Prop. 65”) continued to send hundreds of 60-Day Notices of Violation (“Notices”), as they have during each month of 2020. These Notices challenge the...more

Robins Kaplan LLP

Financial Daily Dose 8.5.2020 | Top Story: Top Story: Ford Removes CEO Jim Hackett After 3 Years on the Job

Robins Kaplan LLP on

Major shakeup at Ford, where CEO Jim Hackett is out after a three-year stint in which he “achieved mixed results” but didn’t impress Wall Street enough to keep his job. Ford has installed COO James Farley, a Toyota alum who’s...more

Haug Partners LLP

INSIGHT: Abbvie Defeats Novel Antitrust Claims Against Humira Patent Estate—Lessons Learned

Haug Partners LLP on

A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an...more

Hogan Lovells

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

Hogan Lovells on

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Prosecution Tool Kit: Implications of the BPCIA on the IP Strategies of Brand Companies and Biosimilar Developers

The enactment of the Biologics Price Competition and Innovation Act (“BPCIA”) in 2010 established for the first time ever in the US an abbreviated pathway for obtaining FDA approval of a new biological product that is deemed...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Holds That Amendments to Biosimilar’s BLA Do Not Trigger Anew BPCIA’s Notice of Commercial Marketing Provision

Under Section 262(l)(8)(A) of the BPCIA, a biosimilar maker must provide notice to the reference product sponsor 180 days before the date of first commercial marketing of the biosimilar.  ...more

Spilman Thomas & Battle, PLLC

Currents - Energy Industry Insights: Issue 25, July 2020

Top Court Seeks Trump Administration Input on PennEast Pipeline - "The U.S. Supreme Court asked the Trump administration for input on a PennEast Pipeline Co. appeal that aims to jump-start a planned natural-gas line by...more

McDonnell Boehnen Hulbert & Berghoff LLP

Immunex Corp. v. Sandoz Inc. (Fed. Cir. 2020)

The Federal Circuit held recently that the "all substantive rights" test, used heretofore to determine the identity of the "patentee" for purposes of satisfying 35 U.S.C. § 281, should be the standard for determining common...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Supplementation of aBLA Does Not Trigger New Notice of Commercial Marketing Obligations

The Federal Circuit held that supplemental applications submitted to the Food and Drug Administration (FDA) to further support approval of a biosimilar product under Section 262(k) of the Biologics Price Competition and...more

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JD Supra Privacy Policy

Updated: May 25, 2018:

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Information for EU and Swiss Residents

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You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Changes in Our Privacy Policy

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Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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