Biosimilars

News & Analysis as of

FDA Accepts the First Biosimilar Application under the BPCIA

Sandoz announced yesterday that the FDA accepted its Biologics License Application (BLA) for filgrastim. This marks the first acceptance of a biosimilars application (351(k)) filed under the pathway created by the Biologics...more

Massachusetts Enacts New Biosimilars Substitution Law

On June 23, 2014, Governor Deval Patrick signed into law House Bill 3734, “An Act Relative to the Substitution of Interchangeable Biosimilars” (now Chapter 143 of the Acts of 2014). The new Act authorizes pharmacists to...more

FDA Publishes New Draft Guidance on Biosimilars As Congress Raises Questions About FDA’s Use of Draft Guidance Documents

As we previously reported, the U.S. Food and Drug Administration (“FDA”) has been drafting guidance regarding the regulation of biosimilars since as early as 2011. A biological product is biosimilar if it is “highly similar...more

Inch-by-Inch: FDA's New Biosimilars Guidance Inches the Industry Closer to Clinical Testing Clarity

For those under cloudy skies for two years, even a small break in the clouds would seem like a bright sunshiny day. The U.S. Food and Drug Administration's (FDA) newest draft guidance on demonstrating biosimilarity largely...more

FDA Releases Draft Guidance on Biosimilars - Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity

The Food and Drug Administration has released the first new Guidance relating to its evolving standards for satisfying the biosimilarity requirements of the Biologics Price Competition and Innovation Act (BPCIA) since its...more

FDA Releases New Guidance for Biosimilar Applications

Yesterday, the U.S. Food and Drug Administration provided further clarity as to how it will evaluate applications for approval of biosimilars when it released a draft guidance document outlining the types of clinical...more

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval

As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal...more

FTC Workshop Seeks to Spark Biosimilars Competition

Demand for biologics is growing fast, but even after Congress passed authorizing legislation in 2010, the pace of generic entry appears to have stalled. Seeking to spur increased generic competition, the FTC held an all-day...more

Clash Of Titans over Biosimilars at FTC Workshop

On Tuesday, February 4, the Federal Trade Commission (FTC) conducted an all-day public workshop at its headquarters in Washington, D.C. on competition issues involving biologics and biosimilars. During highly informative...more

Top Stories of 2013: #11 to #14

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

Recent Ruling Clarifies Patent Litigation Timing Under Biosimilars Act

The first court decision interpreting the Biosimilars Act has arrived, with a federal district court in California finding that a biosimilar application must be filed with the FDA before patent litigation can be initiated....more

No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Action Before Biosimilars Application Is Filed

The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price...more

Sandoz v. Amgen: Interpretation of the Biosimilar Act Results in Dismissal for Lack of Subject Matter Jurisdiction for Declaratory...

On November 11, 2013, the U.S. District Court for the Northern District of California in Sandoz, Inc. v. Amgen, Inc. and Hoffman-La Roche, Inc., Docket No. C-13-2904, made the first-ever judicial interpretation of the...more

Northern District of California Interprets the Biosimilars Act and Limits Declaratory Relief for Biosimilar Manufacturer: What You...

In the first instance of a district court interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (“Biosimilars Act”), Judge Maxine E. Chesney (N.D. Cal.) dismissed a declaratory...more

Biosimilars in the U.S. and Abroad [Video]

Paul Calvo, a director at the intellectual property law firm Sterne, Kessler, Goldstein & Fox, gives viewers a brief update on the status of biosimilars, both in the United States and abroad. He discusses the opposite legal...more

Governor Brown Vetoes California Biosimilar Bill

Last week, Governor Jerry Brown vetoed a California bill (SB-598) that would have authorized a pharmacist to select a biosimilar when filling a prescription order for a prescribed biological product, provided that the...more

California Biosimilar Bill Aligns with BIO Principles on Biologic Substitution

Yesterday, we noted that the Generic Pharmaceutical Association (GPhA) recently expressed its opposition to a California bill (SB-598) that would authorize a pharmacist to select a biosimilar when filling a prescription order...more

GPhA Opposes California Biosimilar Bill; Points to Report on Savings from Biosimilars

Last week, the Generic Pharmaceutical Association (GPhA) released a statement regarding a California bill (SB-598) that the GPhA asserted would "introduce[] burdensome provisions that could raise costs and limit patient...more

Biosimilars Webinar - July 23, 2013

On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop...more

Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not

On March 22, Senators Max Baucus (D-MT) and Orrin Hatch (R-UT), the Chairman and Ranking Member, respectively, of the Senate Committee on Finance, sent a letter to Ambassador Demetrios Marantis, the Acting United States Trade...more

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. ...more

Virginia Enacts Nation’s First Biosimilar Substitution Law

On March 21, 2013, Virginia governor Bob McDonnell signed into law the nation’s first state law concerning substitution of biosimilars. The law’s requirements that pharmacists keep records of substitutions, give notice of...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

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