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Biosimilars

Legislative Update: State Biosimilar Substitution Laws

by Goodwin on

More states continue to enact laws regarding the substitution of biosimilars for prescribed biological products. We have previously reported on the enactment of such laws in New Jersey, Arizona, Missouri, Oregon and...more

Breaking News: FDA Approves Samsung Bioepis’s Biosimilar of REMICADE®

by Goodwin on

Today, FDA approved Samsung Bioepis’s aBLA for RENFLEXIS® (infliximab-abda), a biosimilar of Janssen’s REMICADE®. According to the approved prescribing information, RENFLEXIS® is indicated for the treatment of Crohn’s...more

Congressional Committees Propose Restructuring of User Fees in Draft Language

by Morgan Lewis on

The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases. On April 14, the health committees for both the US Senate and the US House of Representatives released a...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

Celltrion Files for Approval to Sell Herzuma (Trastuzumab) in Japan

by Goodwin on

Celltrion announced last week that it has filed for marketing approval of Herzuma (trastuzumab) with Japan’s Ministry of Health, Labor and Welfare. Herzuma is indicated for the treatment of breast and gastric cancers...more

New State Substitution Laws, and a Busy Spring for Biosimilars

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Amgen Files Reply Brief in Sandoz v. Amgen

by Goodwin on

On April 14, Amgen filed its reply brief in Sandoz v. Amgen. We have previously reported on Sandoz’s response and reply brief, Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief. As we have...more

House and Senate Committees Release Draft Bill that Reauthorizes the User Fee Program for Biosimilars

by Goodwin on

The House and Senate Committees released a draft bill on Friday to reauthorize user fee programs for biosimilars, pharmaceuticals, generic drugs, and medical devices from 2018 to 2022. The bill states that the fees authorized...more

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

Amgen Responds to Genentech’s Letter in Bevacizumab Case

by Goodwin on

As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s application to market a biosimilar of...more

Summary of Sandoz’s Response and Reply Brief in Sandoz v. Amgen

by Goodwin on

On March 31, Sandoz filed its consolidated response and reply brief in Sandoz v. Amgen. We have previously covered Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief. Amgen’s final reply brief is due...more

How Soon Can A Biosimilar Applicant Be Sued for Patent Infringement?

by Fish & Richardson on

Biosimilar manufacturers proceeding under the abbreviated approval pathway laid out in the Biologics Price Competition and Innovation Act (“BPCIA”) open themselves up to patent infringement litigation. But how soon can a...more

Cures Corner: FDA Launches Regenerative Medicine Advanced Therapy Designation Program

by Jones Day on

In late January 2017, FDA took the first steps to implement certain provisions of the 21st Century Cures Act ("Act"), signed into law on December 13, 2016, by launching a new designation program for regenerative medicine...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

Celltrion Reportedly Partnering with George Steuart Health on Sri Lankan Remsima (infliximab)

by Goodwin on

Lanka Business News is reporting that Celltrion and George Steuart Health have teamed up to launch Remsima (infliximab) in Sri Lanka...more

Protective Agreements Before and During BPCIA Litigation: Prosecution and Regulatory Bars

by Fish & Richardson on

Protective orders that regulate the disclosure and use of confidential information exchanged during patent litigations are commonplace. However, the patent dispute resolution procedures under the Biologics Price Competition...more

Trends in Life Sciences: From Data Protection to Drug Pricing

As part of our series on current trends across different industries, we explore current changes taking place in the life sciences field. Privacy & Data Protection - Personal information protection and compliance...more

Eleven Professors File Amicus Brief in Sandoz v. Amgen

by Goodwin on

As we have previously reported, various amicus briefs have been submitted in Sandoz v. Amgen. On March 17, 11 professors submitted an amicus brief in support of Amgen. The 11 professors “teach and write on patent law and...more

Alteogen Reportedly Transferring Biosimilar to Qilu Pharmaceutical

by Goodwin on

Korean Biomedical Review is reporting that Alteogen will transfer technology related to its ALT-L2, a biosimilar of Herceptin, to Qilu Pharmaceutical of China. According to the article, Alteogen and Qilu will “jointly...more

Janssen v. Celltrion, Damages: “Patent Dance” May Determine Availability of Lost Profits

On March 2, 2017, the United States District Court for the District of Massachusetts issued an order in Janssen v. Celltrion explaining that an accused patent infringer’s failure to fully engage in the Biologics Price...more

FDA User Fee Hearings Picking Up Steam on Capitol Hill

As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C)...more

Celltrion Files Two Additional Petitions for IPR of Genentech’s Trastuzumab Patents

by Goodwin on

Celltrion has filed two additional petitions for inter partes review of Genentech patents related to trastuzumab: IPR2017-01139, challenging U.S. Patent 6,627,196, and IPR2017-01140, challenging U.S. Patent 7,371,379....more

EC Approves Amgen’s Biosimilar Adalimumab

by Goodwin on

Amgen announced yesterday that the European Commission (EC) has granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications, including certain adult and pediatric inflammatory diseases. ...more

[Webinar] Pharmaceutical Life Cycle Management: Updates on Navigating the IP, FDA and Antitrust Terrain - April 5th, 12:00pm EST

by BakerHostetler on

There’s been a sea change in the political climate. The regulatory forecast is still uncertain, and pharmaceutical evolution continues to develop....more

Janssen’s Amicus Brief Sandoz v. Amgen

by Goodwin on

As we posted here, here, and here, various amicus briefs have been submitted in Sandoz v. Amgen. Last week, Janssen Biotech, Inc. submitted an amicus brief in support of Amgen....more

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