Biologics

News & Analysis as of

Final WHO Biosimilar Naming Proposal Resembles FDA Approach

On January 26, 2016, the World Health Organization (WHO) unveiled the final version of its proposal for a worldwide biosimilar naming convention. The WHO proposes to add a “biologic qualifier” (BQ) suffix, which consists of...more

U.S. Biosimilar Litigation So Far

The U.S. biosimilars statute, the Biologics Price Competition and Innovation Act (“BPCIA”), was enacted in 2010 as part of the Affordable Care Act. Nearly six years later, the number of reported decisions addressing the...more

Health Update - January 2016

The Megatrends Reshaping Healthcare: Managing Change and Maximizing Opportunity - Editor's Note: In 2013, Manatt Health identified 10 megatrends that would reinvent the healthcare marketplace across the next decade. In a...more

FTC Approves Tornier and Wright Medical Merger

The U.S. Federal Trade Commission (FTC) recently issued a final order that conditionally approves the merger between Amsterdam, Netherlands-based Tornier N.V. and Memphis, Tennessee-based Wright Medical Group, Inc. Reuters...more

Australian Patent Office guidelines finalised post-Myriad

The Australian Patent Office has now finalised what will be their approach to examining nucleic acids and other biological inventions following the decision handed down by the High Court in D'Arcy v Myriad Genetics Inc [2015]...more

Ten Years of Biosimilars in Europe

This fall marks the tenth anniversary of the effective date of the European Medicines Agency’s Guideline on Similar Biological Medicinal Products. As this blog noted previously, the EU’s biosimilar pathway both preceded the...more

With Trans-Pacific Partnership Negotiations Concluded, Administration Turns to Clearing Domestic Hurdles

The working text (all 5,500+ pages) of the 12-country Trans-Pacific Partnership Agreement (TPP) was released to the public on November 5. This text is still undergoing an intense legal scrub and must be translated into its...more

BPCIA: Amgen Begins the Patent Dance With AbbVie

On November 25, 2015, Amgen Inc. (“Amgen”) announced it submitted its first biologics license application (“BLA”) to the FDA under the Section 351(k) biosimilar approval pathway provided in the Biologics Price Competition and...more

Breaking News - FDA Generic Drug Anti-Preemption Proposal Again

We just read on 360 this morning that the FDA has again postponed its schedule for finalizing the generic drug labeling changes (the so-called "Supplemental Applications Proposing Labeling Changes for Approved Drugs and...more

FDA Finalizes Guidance For Formal Meetings Between the FDA and Biosimilars Applicants

On November 17, 2015, the FDA finalized a guidance document, that was first issued as a draft in March 2013, regarding formal meetings between the FDA and biosimilars applicants. Because meetings with biosimilars applicants...more

Intellectual Property Issues Under the Trans-Pacific Partnership | Orange County Business Journal

The recently announced Trans-Pacific Partnership (TPP), a multi-national trade agreement between Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam, and the United...more

GAO Examines Trends in Medicare Part B Expenditures for New Drugs and Biologicals

The Government Accountability Office (GAO) has issued a report describing trends in Medicare Part B spending and utilization for “new” drugs and biologicals (approved by the FDA from 2006 through 2013). The GAO’s analysis is...more

Naming of Interchangeable and Biosimilar Biological Products Likely to Be Same

Earlier this fall, FDA issued a draft guidance proposing a middle-road approach to naming biosimilars. Unlike small-molecule drugs, where the branded and generic drug share the same nonproprietary name (also referred to as a...more

What Are the IP Provisions of the TPP?

The Obama Administration released the approved text of the Trans Pacific Partnership (TPP) agreement last week, and it is substantially (and perhaps entirely; there has not been sufficient time to compare) the same as the...more

Obama Administration Releases Much Anticipated Text of the Trans-Pacific Partnership Agreement

This client alert examines intellectual property proposals in the Trans-Pacific Partnership from the perspective of biotechnology, pharmaceutical, and chemical industries. On November 5, 2015, the U.S. trade...more

Final Text of Trans-Pacific Partnership Released

At long last, the final text of the Trans-Pacific Partnership, a free trade agreement among a dozen Pacific Rim nations, has now been made available to the public. The chapter on intellectual property, however, does not...more

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more

BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?

In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more

Trans-Pacific Partnership Has Challenges, Opportunities for U.S. Companies

The U.S. and its 11 negotiating partners – Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam – reached preliminary agreement on October 5, 2015, on the Trans-Pacific...more

What impact will the Australian Myriad decision have on patent eligibility of diagnostic tests?

By now most will know that: (a) Australia’s final appeal Court has made adverse findings against Myriad’s patent for utilising the BRCA1 locus to diagnose breast cancer; (b) the rejected claims are only those that...more

A Split Decision Remains Split; No en banc Review of Amgen v. Sandoz

On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more

California Becomes Latest State to Pass Biosimilar Substitution Law

On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more

What May Be the IP Provisions of the Trans Pacific Partnership Agreement

The diplomats negotiating the Trans Pacific Partnership (TPP) agreement have done the seemingly impossible: they have kept the details of the draft agreement secret from the press and interested parties in the United States,...more

Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more

Washington Healthcare Update

On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

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