Tag: Biologics

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Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®
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The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling
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Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance
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Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional
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Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to Address BPCIA Interpretation
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Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants
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Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures
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FDA Accepts First Biosimilar Application Filed Under Section 351(K) of the Public Health Services Act
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Biosimilars – The New Forefront for Pharmaceutical Litigation

Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®

The United States biosimilars market is beginning to grow, with two recent approvals for biosimilars: Erelzi® and Amjevita®.

On August 30, 2016, the Food & Drug Administration (“FDA”) approved Sandoz’s application for a biosimilar of Enbrel®.  The product is called Erelzi and is the first biosimilar of etanercept to be approved by the FDA.  Like Enbrel, Erelzi is administered by injection and is approved to treat moderate to severe rheumatoid arthritis and moderate to severe plaque psoriasis, among other conditions.  Erelzi is approved as a biosimilar, not interchangeable, product. It is identified as etanercept-szzs.

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The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”).  As of now, the FDA has adopted the same labeling approach as used for generic pharmaceutical drugs.  However, AbbVie argues in its petition that “[b]iosimilars are not generic drugs and should not be labeled like generic drugs.”

To read the full alert, click here.

Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance

As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that the FDA mandate compliance with the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) information exchange provisions, often referred to as the “Patent Dance.” In particular, Amgen requested that the FDA require a biosimilar applicant to certify that it will timely comply with Section 351(l)(2)(A) of the BPCIA by providing the brand holder with a copy of the biosimilar application and information describing the process(es) used to manufacture the biosimilar product covered by the application.

To read the full alert, click here.

Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional

The biologics industry has been closely monitoring Amgen Inc.’s (“Amgen’s”) lawsuit against Sandoz Inc. (“Sandoz”) for refusing to engage in the BPCIA’s “patent dance” with respect to Sandoz’s application for Zarxio®, a biosimilar of Amgen’s Neupogen® (filgrastim), to see what, if any, guidance the district court would provide on the interpretation of the BPCIA. See Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures. This litigation has sparked additional interest in view of FDA’s recent approval of Zarxio®, which has led to industry-wide speculation regarding the litigation’s potential impact on Sandoz’s ability to market its now approved biosimilar. See FDA Approves First Biosimilar: Sandoz’s Zarxio®. The District Court of the Northern District of California has now provided an answer, siding with Sandoz’s interpretation that the BPCIA’s patent dance provisions are optional and the 180 day notice provision does not require licensure, and denying Amgen’s request for a preliminary injunction.

To read the full alert, click here.

Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to Address BPCIA Interpretation

The biologics industry has been eagerly awaiting the Federal Circuit’s ruling on Sandoz Inc.’s (“Sandoz”) appeal from the United States District Court for the Northern District of California’s dismissal of its declaratory judgment action due to lack of Article III jurisdiction. In particular, the industry has been waiting to see whether the Federal Circuit would uphold the district court’s ruling that Sandoz’s lawsuit was barred by the Biologics Price Competition and Innovation Act (“BPCIA”). Unfortunately, the Federal Circuit declined to address the district court’s interpretation of the BPCIA, providing no further guidance on the topic. Instead, the Federal Circuit simply affirmed the district court’s ruling that there was no subject matter jurisdiction, relying on Hatch-Waxman generic drug cases as precedent.

To read the full alert, click here.

 

Declaratory Judgment Action Premature: Decision Suggests “Patent Dance” Mandatory for Biosimilar Applicants

Biosimilar applicants and branded biologics have been wondering how the procedures set forth in the Biologics Price Competition and Innovation Act (“BPCIA”) will be implemented since its enactment in 2010. The lack of guidance on this subject has already sparked litigation, including the recent litigation between Amgen Inc. (“Amgen”) and Sandoz Inc. (“Sandoz”) discussed in our previous client alert, Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures. However, Amgen and Sandoz are not the only parties that have brought disputes involving the BPCIA to the courts for resolution.

To read the full alert, click here.

Left without a Partner: Amgen Sues Sandoz for Refusing to Dance in Accordance with BPCIA Patent Procedures

There has been a lot of curiosity within the biologics industry regarding how the “patent dance” procedures of the Biologics Price Competition and Innovation Act (“BPCIA”) would operate. This interest was piqued in July 2014 when Sandoz Inc.’s (“Sandoz”) biosimilar application for a biosimilar of Amgen Inc.’s (“Amgen”) Neupogen® was the first accepted by FDA under section 351(k) of the Public Health Service Act. Apparently, Sandoz has refused to engage in the “patent dance” in accordance with the BPCIA, leaving Amgen without a dance partner. Amgen did not take kindly to being stranded on the dance floor and has opted to sue Sandoz for its allegedly unlawful refusal to follow the BPCIA’s patent resolution procedures.

To read the full alert, please click here.

FDA Accepts First Biosimilar Application Filed Under Section 351(K) of the Public Health Services Act

On 24 July 2014, over four years after the enactment of the Biologics Price Competition and Innovation Act, the FDA accepted its first biosimilar application from Sandoz Inc. (Sandoz). Sandoz’s application is for a biosimilar version of Amgen Inc.’s (Amgen) Neupogen® (filgrastim). Neupogen® is a pharmaceutical analog of human granulocyte colony stimulating factor that is used to treat neutropenia, a condition where the body does not make enough neutrophils, a type of white blood cell. Amgen’s Neuprogen® is indicated for use by patients receiving strong chemotherapy to reduce their risk of infection.  Read More

Biosimilars – The New Forefront for Pharmaceutical Litigation

A recent United States statute establishes an expedited pathway for FDA approval of biosimilars (also known as follow-on biologics) – the Biologics Price Competition and Innovation Act (BPCIA), part of the Affordable Care Act. A biologic is a drug derived from a living organism or living cells and is best exemplified by Humira®, the branded antibody for treatment of rheumatoid arthritis. Simply put, a biosimilar is a molecule that copies a branded biologic and is for all practical purposes highly identical to the branded biologic in structure and function.  Read More

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