News & Analysis as of

Biosimilars

Samsung Bioepis and Merck & Co. Launch Renflexis, A Lower-Priced Competitor to Inflectra

by Goodwin on

Merck & Co. and Samsung Bioepis announced today the U.S. launch of Renflexis (infliximab), a biosimilar of Janssen’s Remicade. Renflexis was approved on April 21 by the FDA for all eligible indications. ...more

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

by Knobbe Martens on

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the...more

Approved Biosimilar Products Around The world

Please see full chart below for approved biosimilar products around the world. ...more

Biosimilar Uptake and Patent Litigation in Japan

Biosimilar uptake in Japan has been a bit mixed, but according to experts the volume shares of biosimilars suggests it could be a key market in years to come. The Pharmaceuticals and Medical Devices Agency (PMDA), which is...more

Pharma and Biologics Disputes in Canada—Big Changes for Big and Small Molecule Litigation

by Bennett Jones LLP on

The patent litigation that propels generic and biosimilar products to market will soon change dramatically. July 15, 2017, marked the release of long-awaited proposed amendments to the Patented Medicines (Notice of...more

Biosimilars in Europe

Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more

Sandoz Files Two Petitions for IPR of Two AbbVie Patents Related to Humira

by Goodwin on

Sandoz has filed a petition for inter partes review of AbbVie’s U.S. Patent No. 8,802,100 (IPR2017-01823), which claims stable formulations of an anti-TNFa antibody identified in the petition as Humira® (adalimumab). Sandoz...more

Coherus Challenges One AbbVie Humira Patent In Four PTAB Proceedings

by Foley & Lardner LLP on

I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same...more

CMS Considers New Billing Code Policy for Biosimilars

by Goodwin on

Last week, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule regarding payment policies. Among other things, the proposed rule included a request for comment on the policy for biosimilar...more

You Can Dance If You Want To

In borrowing a page from the '80s band "Men Without Hats," on June 12, 2017, the U.S. Supreme Court brought greater certainty for both biosimilar applicants and originator companies. In Sandoz Inc. v. Amgen Inc., the Supreme...more

FDA Committee Recommends Approval of Bevacizumab and Trastuzumab Biosimilars

by Goodwin on

The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously supported biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab). Amgen and Allergan’s Avastin biosimilar candidate, ABP...more

Global Patent Prosecution Newsletter - July 2017

Biosimilars Around the World - Last month’s Supreme Court ruling in Sandoz v. Amgen brought greater certainty to both biosimilar applicants and originators in the United States. The July 2017 issue of Sterne Kessler’s...more

First U.S. Avastin and Herceptin Biosimilars

On Thursday, July 13, 2017, FDA’s Oncological Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilars of two blockbuster cancer drugs. The first, Amgen and Allergan’s ABP-215, is a proposed biosimilar...more

Pfizer Takes Aim at Herceptin® Patent at the PTAB

by Fish & Richardson on

Pfizer has shown its muscle in the biosimilars field, purchasing Hospira in 2015 and launching the second biosimilar on the U.S. market, Inflectra® (infliximab), a biosimilar of Johnson & Johnson’s Remicade®. Pfizer is now...more

EMA’s Issues Statement of Non-Compliance for Biocon’s Biosimilar Manufacturing Facility

by Goodwin on

As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, and they have filed applications for marketing authorization in the European Union for three biosimilar products: Fulphila...more

The Travails of the First U.S. EPO Biosimilar

Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more

Review Article Supports Interchangeability of Infliximab and CT-P13

by Goodwin on

Last week, an article reviewing the literature comparing infliximab biosimilar CT-P13 (Celltrion) with infliximab (Janssen Biotech) for the treatment of rheumatologic diseases was published in Drug Design, Development and...more

Sandoz Inc. v Amgen Inc.

by Hodgson Russ LLP on

Artificial patent infringement occurs when certain types of approval applications are submitted to the U.S. Food And Drug Administration (the “FDA”). The U.S. Supreme Court recently considered a situation in which an...more

Discontinuation of Etanercept Biosimilar in Japan

by Goodwin on

On July 5, 2017, Daiichi Sankyo Company announced that it has decided to discontinue the development of CHS-0214, an investigational biosimilar to Amgen’s Enbrel® (etanercept), in Japan. Daiichi had been co-developing...more

Coherus Implements Restructuring Plan Following Complete Response Letter For Its Pegfilgrastim Biosimilar

by Goodwin on

As we reported here on June 12, 2017, Coherus BioSciences received a complete response letter (“CRL”) from the FDA for its biologics license application for its pegfiltrastim (Neulasta®) biosimilar. On June 21, 2017, in a...more

Supreme Court Decision Allows Faster Marketing of Biosimilars

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more

Janssen and Celltrion: Remicade Biosimilar Patent Dance

by Knobbe Martens on

Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, as required by the Biologics Price Competition...more

Biosimilar Notice May Be Given Prior to FDA Approval

by McDermott Will & Emery on

In a unanimous decision, the Supreme Court of the United States explained that under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), biosimilar makers do not have to wait for approval before giving 180-day...more

ITC Section 337 – Quarterly Highlights

by Hogan Lovells on

SCOTUS Narrows Opportunity For ITC Section 337 Jurisdiction Over Imported Biosimilars Based On 180-Day Notice Provision - In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1357-58 (Fed. Cir. 2015), the Federal Circuit held that...more

FDA accepts Celltrion/Teva BLA for biosimilar of Rituxan®

by Goodwin on

Celltrion and Teva announced today that the FDA has accepted for standard review their BLA for CT-P10 and that regulatory action is expected in the first quarter of 2018. CT-P10 is a proposed biosimilar to Rituxan®...more

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