News & Analysis as of

Biosimilars

Samsung Bioepis’s Etanercept Biosimilar Said to be Less Immunogenic than Enbrel

by Goodwin on

A research letter published by the British Journal of Dermatology from investigators in Samsung Bioepis’s biosimilar etanercept (SB4) clinical trials reports that, in addition to therapeutic equivalence between SB4 and...more

Biosimilar Market Developments Continue Apace in 2018

It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....more

FDA Accepts Sandoz aBLA for Adalimumab Biosimilar

by Goodwin on

Sandoz, a division of Novartis, announced on Tuesday that the FDA has accepted for review its BLA under the 351(k) pathway for a biosimilar candidate to AbbVie’s Humira (adalimumab). According to the press release, adalimumab...more

FDA Announces Release of 2018 Strategic Policy Roadmap

by Goodwin on

On January 11, FDA announced the release of its 2018 Strategic Policy Roadmap, which provides an overview of several policy areas that FDA intends to focus on in 2018. FDA noted that, among these policy areas, it planned to...more

France Aims for 80% Biosimilar Penetration by 2022

by Goodwin on

In its 2018-2022 National Health Strategy, France aims for 80% biosimilar penetration by 2022, an increase from last year’s 70% target. France’s support for biosimilars is not new. ...more

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

by Smart & Biggar on

The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Update on Biosimilar Testing: Cinfa, Mylan/Biocon, Sandoz

by Goodwin on

Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that...more

State Law Cannot Circumvent Congress’s Scheme for Biologics

In Amgen v. Sandoz, No. 2015-1499, the Federal Circuit affirmed the Northern District of California’s decision that Sandoz had not waived its preemption defense and that the Biologics Price Competition and Innovation Act of...more

Hetero and Glenmark Launch Adalimumab Biosimilars in India

by Goodwin on

Hetero announced this week the launch in India of its adalimumab biosimilar, marketed under the brand name Mabura. Mabura is a biosimilar of Abbvie’s Humira and is indicated for the treatment of rheumatoid arthritis and other...more

Study Concludes Samsung Bioepis’ Adalimumab Biosimilar Equivalent to Humira®

by Goodwin on

We previously posted that in August 2017, Samsung Bioepis’ adalimumab biosimilar, SB5 (also known as Imraldi®), was granted marketing authorization by the European Commission. In September, it also won approval from the South...more

Momenta and Mylan Collaborating to Develop Biosimilar of Eylea® (aflibercept)

by Goodwin on

Yesterday, Momenta Pharmaceuticals and Mylan announced a development strategy for M710, a proposed biosimilar of Regeneron’s Eylea® (aflibercept), including their plan to initiate a pivotal clinical trial in the first half of...more

Mylan and Biocon Gain Approval for Trastuzumab Biosimilar in Brazil

by Goodwin on

On December 29, Mylan and Biocon announced that their trastuzumab biosimilar, Zedora, was approved by Brazil’s National Sanitary Surveillance Agency. Zedora, a biosimilar of Genentech and Roche’s Herceptin, is indicated for...more

FDA Approves the First Gene Therapy to Treat an Inherited Disease

On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and adults with biallelic REP65 mutation-associated retinal dystrophy, an inherited...more

Year in Review: Top 5 Biosimilars Deals of 2017

by Goodwin on

Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017...more

Year in Review: Top Five Legal Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more

Year in Review: The Top-Five U.S. Market Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

Year in Review: Top 5 Foreign Market Developments in 2017

by Goodwin on

Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2017...more

Federal Circuit Rules BPCIA Preempts State Law

by Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Biosimilars: Strategic Considerations for 2018

by Polsinelli on

2017 was an eventful year for biosimilars in the U.S. As the number of biosimilar filings increased, important legal and regulatory decisions changed the strategic landscape of the biosimilars market for both innovators and...more

Federal Circuit Finds Preemption Of State Law Penalty For Sitting Out Biosimilar Patent Dance

by Foley & Lardner LLP on

The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not...more

American College of Rheumatology Identifies Six Factors for Future FDA Biosimilar Oversight

by Goodwin on

In response to an FDA request for comments regarding existing requirements for biologics and biosimilars, the American College of Rheumatology (ACR) submitted a letter identifying six “minimum components of review and...more

Federal Circuit Issues Mandate in Amgen v. Apotex

by Goodwin on

As we previously reported, last month a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s protein refolding method...more

FDA Accepts Samsung Bioepis’ aBLA for Herceptin® Biosimilar

by Goodwin on

Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s Herceptin® (trastuzumab). The press release states...more

Worldwide Bolar-type Provisions*

Please see full chart for Bolar Excemption rules in foreign countries regarding Clinical Trials, New Drugs, Biosimilars and Foreign Jurisdiction issues. ...more

Federal Circuit Speaks Regarding State Law Remedy for BPCIA’s “Patent Dance”

On December 14, 2017, the Federal Circuit issued a unanimous decision in Amgen Inc. v. Sandoz Inc., No. 2015-1499, interpreting whether the Biologics Price Competition and Innovation Act (BPCIA) is subject to state law...more

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