News & Analysis as of

Biosimilars

FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT® Biosimilar

by Goodwin on

As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer,...more

BPCIA Litigation Roundup (Spring 2017)

by Goodwin on

Below is our spring update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

Cinfa Biotech Announces Positive Clinical Trial Results for Neulasta Biosimilar

by Goodwin on

Cinfa Biotech, a Spanish company focusing on the development of biosimilars, announced positive results from their second clinical trial evaluating a biosimilar version of Amgen’s Neulasta (pegfilgrastim). According to the...more

Changes coming soon for pharmaceutical patent litigation in Canada: key points

by DLA Piper on

As a result of the Comprehensive Economic Trade Agreement with the European Union, significant changes to the patent linkage provisions and patent litigation framework relating to generic and biosimilar drug approval in...more

Public Comment Period Closes for FDA’s Draft Interchangeability Guidance

by Goodwin on

On May 19, 2017, the period for submitting public comments on the FDA draft guidance on biosimilar interchangeability closed (for a discussion of the FDA draft guidance click here). The draft guidance was published on...more

Changes to pharmaceutical/biopharmaceutical patent litigation in Canada

by DLA Piper on

As a result of the Comprehensive Economic Trade Agreement with the European Union, significant changes to the patent linkage provisions and patent litigation framework relating to generic and biosimilar drug approval in...more

Practical Issues for the Pharmaceutical and Biopharmaceutical Industry in the Wake of TC Heartland

The US Supreme Court this week held that the broad venue provision of 28 U.S.C. § 1391(c) does not apply to patent law—at least, when the defendant is a domestic entity. This decision arises after years of judicial...more

PTAB Invalidates Patent for Blockbuster Drug HUMIRA®

The PTAB issued a Final Written Decision in Coherus BioSciences Inc. v. AbbVie Biotechnology Ltd., IPR2016-00172 (P.T.A.B. May 16, 2017) finding claims 1-5 of U.S. Patent No. 8,889,135 (“the ‘135 patent”) unpatentable....more

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more

Materials Available for May 25, 2017 ODAC Meeting Regarding Hospira’s Epoetin Alfa Biosimilar Application

by Goodwin on

As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit®...more

Coherus Responds to Apotex Citizen Petition Seeking Heightened Regulatory Requirements For Biosimilar Competition

by Goodwin on

We previously reported that Apotex filed a Citizen’s Petition requesting that FDA require biosimilar applicants to conduct comparative clinical efficacy studies in at least one intended patient population, rather than...more

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

AAM/Biosimilars Council Comments on FDA Draft Guidance on Interchangeability

by Goodwin on

The Association for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, released comments today on FDA’s Draft Guidance on Considerations in Demonstrating Interchangeability With a Reference Product...more

Update on Biosimilar Approvals and Pending Applications in Europe and the U.S.

Approvals of biosimilar products in Europe continue to outpace those in the United States. 28 biosimilars are currently approved in Europe and five in the U.S. In 2017, the European Medical Agency has approved six...more

New BPCIA Litigation: Janssen v. Samsung Bioepis (D.N.J.)

by Goodwin on

On May 17, 2017, Janssen filed a complaint under the BPCIA in the District of New Jersey against Samsung Bioepis Co., Ltd. regarding Renflexis® (infliximab-abda), Samsung Bioepis’s recently approved biosimilar of Remicade®....more

Capitol Hill Healthcare Update

by BakerHostetler on

Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after...more

Dr. Reddy’s to Install GE Healthcare’s FlexFactory

by Goodwin on

GE Healthcare announced today that Dr. Reddy’s will install GE Healthcare’s FlexFactory in Dr. Reddy’s facility in Hyderabad, India. According to the press release, “FlexFactory will help Dr. Reddy’s increase its capacity to...more

Scott Gottlieb’s Stance on Biosimilars

by Goodwin on

On May 11, 2017, Scott Gottlieb was sworn in as the 23rd Commissioner of the U.S. Food & Drug Administration. Before his confirmation, Gottlieb was vocal about his disapproval of the FDA’s “well-established” attitude: an...more

Amgen Sues Coherus Under BPCIA After Completing Patent Dance

On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S....more

Fish Client Coherus BioSciences Prevails in ‘135 IPR Decision

by Fish & Richardson on

REDWOOD CITY, Calif., May 16, 2017 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (Nasdaq:CHRS), announced that the Patent Trial and Appeal Board (“PTAB”) of the U.S. Patent and Trademark Office ruled in favor of Coherus’...more

Results of Danish Infliximab Biosimilar Switching Study Published

by Goodwin on

Researchers in Denmark recently published a report from an observational study of 802 Danish patients who switched from Remicade to the biosimilar infliximab product Remsima for the treatment of rheumatoid arthritis,...more

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

by Jones Day on

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

Congressional Panels Tackle FDA Reauthorization Act and Other Health Policy Issues

by Reed Smith on

On May 11, 2017, the Senate on Health, Education, Labor, and Pensions (HELP) Committee approved S 934, a bill extend Food and Drug Administration user-fee programs for prescription drugs, medical devices, generic drugs, and...more

100 Days Plus Under Trump: What They Mean for Biologics

President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more

Update on Recommendations and Initiatives of EU Regulators Ahead of Brexit

by Jones Day on

On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more

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