News & Analysis as of

Biosimilars

The Herceptin® Battle Moves into the District Court

by Fish & Richardson on

On November 17, 2017, Genentech filed suit against Pfizer in the District of Delaware, alleging that Pfizer’s biosimilar of Herceptin® infringes forty Genentech patents covering Herceptin® and its methods of use and...more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...more

Amgen Files Reply in Support of Motion to Transfer Bevacizumab Action to California

by Goodwin on

We previously reported on Genentech’s complaint in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents and Amgen’s motion to transfer that complaint to the Central...more

Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit

On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s...more

Genentech Files Complaint Against Pfizer Regarding Herceptin

by Goodwin on

Genentech filed a complaint last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab). According to the...more

Samsung Bioepis Receives EU Marketing Authorization For Trastuzumab Biosimilar

by Goodwin on

Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European...more

Federal Circuit Evaluates Import of Factual Statements Made During BPCIA Pre-litigation Patent Dance

In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for biosimilar versions of Neulasta® and Neupogen® did...more

Sandoz Announces New Data For Its Adalimumab And Rituximab Biosimilars

by Goodwin on

On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®. We previously reported that the Sandoz...more

FDA Announces New Draft REMS Guidance

by Goodwin on

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all...more

Federal Circuit Provides Guidance on Probative Value of “Patent Dance” Letters and aBLA Parameters in an Infringement Analysis

by Fish & Richardson on

On November 13th, in an opinion drafted by Judge Taranto, the Federal Circuit affirmed the Southern District Court of Florida’s judgment that Apotex’s biosimilar versions of Neulasta® and Neupogen® do not infringe Amgen’s...more

Federal Circuit Provides Guidance on Statements in Patent Dance Letters and Sunovion in Amgen v Apotex

by Goodwin on

As we previously reported, on November 14, 2017, the Federal Circuit affirmed the Southern District of Florida’s finding of non-infringement in Amgen v. Apotex. In that case, Amgen asserted the ’138 patent against Apotex...more

Federal Circuit Affirms District Court in Amgen v. Apotex

by Goodwin on

As we previously reported, Amgen appealed the Southern District of Florida’s judgment of non-infringement in favor of Apotex in litigation regarding Apotex’s proposed filgrastim and pegfilgrastim biosimilars. Today the...more

Boehringer Ingelheim’s First Biosimilar Is Approved in Europe

by Goodwin on

Boehringer Ingelheim (BI) announced today that it received marketing authorization in Europe for Cyltezo®, which is a biosimilar to Humira®. Cyltezo® was approved for the treatment of multiple chronic inflammatory diseases in...more

Biosimilars Update: Amgen, Allergan, Pfenex, Cinfa

by Goodwin on

Below are regulatory and development updates regarding a number of biosimilar candidates. Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...more

CMS Announces New Policy for Biosimilars Payments Under Part B

by Goodwin on

As we previously reported, the Centers for Medicare and Medicaid Services (“CMS”) has been considering comments on a proposed rule regarding biosimilar payment policies. On Thursday, CMS issued a final rule for the 2018...more

New Data Supports Efficacy and Safety of Boehringer Ingelheim’s Cyltezo, a Humira Biosimilar

by Goodwin on

Today, Boehringer Ingelheim announced new one-year data for their adalimumab biosimilar, Cyltezo®. VOLTAIRE®-RA, a 48 week Phase III clinical trial, compared Cyltezo® (adalimumab-adbm) to Humira. The results showed that...more

Q3 Earnings Round-up

by Goodwin on

Below are some highlights from third quarter earnings reports recently released by biologics and biosimilar companies....more

Biosimilar Litigation Updates

by Goodwin on

Below is an update on recent developments in several litigations involving biosimilar products. AbbVie v. Boehringer Ingelheim (adalimumab): On October 23, the parties filed a joint status report. ...more

Momenta’s Orencia (abatacept) biosimilar candidate M834 does not meet primary endpoints in Phase I study

by Goodwin on

Yesterday, Momenta and Mylan reported that initial results obtained from their proposed abatacept biosimilar M834 did not meet primary pharmacokinetic endpoints in a Phase I study comparing the pharmacokinetics, safety and...more

Pfizer and Celltrion Healthcare Reveal New Data For infliximab biosimilar Inflectra®

by Goodwin on

Last year we reported the FDA approval and then U.S. launch of Inflectra®, a biosimilar of Remicade® (infliximab). This week, Pfizer and Celltrion Healthcare have reported that the results of a Phase 3 study of Inflectra...more

Updates on Sandoz’s Pegfilgrastim Biosimilar / Amgen v. Sandoz

by Goodwin on

Today, Sandoz announced that its biosimilar of Neulasta® (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review. According to the press release, the data package submitted as part of...more

Amgen and Genentech Break New Ground in Avastin Biosimilar Dispute

Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab). On October 6, in a complaint filed in the Central District of California,...more

Lawsuits Filed on the Same Day Regarding Amgen’s Avastin® Biosimilar

by Morgan Lewis on

The cases show that—even given a recent US Supreme Court interpretation of the statute—uncertainty still exists about complying with the “patent dance" information exchange requirements under the Biologics Price Competition...more

FDA Releases Biosimilars Educational Materials

by Goodwin on

On October 23, 2017, FDA announced the release of new educational materials to help health care professionals understand what biosimilars are and how they are approved. The materials include four fact sheets and graphics that...more

Study concludes that data supports switching from Remicade® to biosimilar Renflexis®

by Goodwin on

A recent study evaluated the efficacy, safety, and immunogenicity of switching from reference infliximab (Remicade®, Janssen Biotech), to the biosimilar SB2 (Renflexis®, Samsung Bioepis), in patients with moderate to severe...more

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