Biosimilars

News & Analysis as of

An Inflectra Update: Janssen Requests an Expedited Trial

As we reported last week, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-a antibody. On Tuesday, April 12,...more

The Next Move in the Name Game: FDA Provides Long-Awaited Draft Guidance on Biosimilar Labeling

On March 31, 2016, the U.S. Food and Drug Administration (FDA) released its long-awaited Draft Guidance on labeling for biosimilar products (the “Draft Guidance”) and is currently soliciting comments on its proposals. The...more

Janssen Seeks Expedited Trial Following FDA Approval of Remicade Biosimilar

Biosimilar litigation and the implications of the BPCIA are continuing to unfold in light of the FDA’s April 5, 2016 approval of Celltrion’s biosimilar of Janssen’s Remicade (infliximab). This is only the second biosimilar...more

FDA Issues Draft Guidance on Labeling For Biosimilar Products

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products....more

Amgen Hedges Its Bets With Cross-Petition For Certiorari Of Biosimilar Decision

Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more

Washington Healthcare Update

This Week: MedPAC votes on changes in Part D... Senate HELP Committee reports five “Cures” bills... One report shows uninsured number decreasing... Another says, but we still need the safety net. ...more

FDA Biosimilars Guidance Not Conducive To Preemption

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...more

FDA Announces Approval of Second U.S. Biosimilar

On April 5, the FDA issued its approval for Inflectra, Celltrion and Pfizer’s biosimilar of Johnson & Johnson’s Remicade (infliximab). Inflectra is now the second biosimilar approved for sale in the United States, after...more

FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar

The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar – Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer...more

Update on Enbrel Biosimilar and Related US Litigation

Amgen’s Enbrel (etanercept), a blockbuster biologic treatment for a number of autoimmune diseases, including rheumatoid arthritis and psoriasis, has been an attractive target for biosimilar makers. Sandoz, the maker of...more

Health Care Update - April 2016

FDA Reform Tops Spring Work Period Agenda - The next work period basically runs from April 4 to May 27, with a both chambers adjourning for a week long recess the week of May 2nd. Following this work period, there will...more

FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar

Earlier today, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-a antibody. This marks only the second...more

Biosimilar Developments Continue at a Rapid Pace

As our regular readers know, we’ve been tracking regulatory approvals, reimbursement policies, pharmacy substitution laws, and other developments related to biosimilar biological products. Biosimilars rely on the safety and...more

FDA Guidance for Biosimilar Labeling Largely Stays with Generic Model

On Thursday, FDA released draft guidance clarifying its position on labeling biosimilar products. While the guidance addresses some of the concerns raised by physicians and industry, FDA’s guidance mostly continues to treat...more

FDA Differentiates Biosimilar Labeling from Generic Drug Labeling

In another highly anticipated regulatory move, FDA has released draft guidance on “Labeling for Biosimilar Products.” Made public on March 31st, the draft guidance sets forth FDA’s recommendations on the labeling of...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more

Amgen Opposes Sandoz’s BPCIA Cert Petition and Files Conditional Cross-Petition on Patent Dance

Amgen has fired back in response to Sandoz’s cert petition in Amgen v. Sandoz, arguing that the Supreme Court should not hear the case—but that if it does, it should also review the Federal Circuit’s holding on the Biologics...more

[Webinar] Recent Legal & Economic Developments That Affect Your Biotech Business - March 29th, 2:00pm EST

The greatest asset of a young biotech company is its intellectual property. Strategic decisions made during the initial organization and early growth of your company have a lasting impact on its success. In this webinar, we...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

M&A: The Last Refuge for Biotechs Seeking Funding

These are tough times in the biotech and pharmaceutical industries: Funding is drying up, investors are fleeing the space, the IPO door is pretty firmly shut, valuations are dropping, activists are lurking and the headlines...more

Sandoz Sued for Cutting Short BPCIA “Patent Dance” for Neulasta Biosimilar

Although there have only been a handful of disputes involving the U.S. biosimilars statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA), Amgen and Sandoz have been the protagonists in four of them. In...more

Washington Healthcare Update

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

Amgen files Declaratory Judgment Action against Sandoz over NEULASTA® Biosimilar

Last Friday, Amgen filed a declaratory judgment action in the District Court for New Jersey against Sandoz, in the latest iteration of biosimilar litigation between the parties (see complaint). Amgen's and Sandoz's actions...more

Amgen Launches Enbrel Biosimilar Patent Litigation

Although Sandoz’ application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act...more

Does the "Notice of Commercial Marketing" Provision in the BPCIA Stand Alone? -- Amgen v. Apotex Case Preview

According to the Federal Circuit website, the appeal from the Amgen Inc. v. Apotex Inc. case will be argued on April 4, 2016 in Courtroom 402. This case is an appeal from a decision by Judge Cohn of the Southern District of...more

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