Biologics

News & Analysis as of

Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more

Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible...more

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures

Amgen, Inc. (“Amgen”) has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA-2014-P-1771) on October 29, 2014 (“Petition”) requesting...more

Biological Products: New FDA Draft Guidance Sheds Light on Reference Product Exclusivity

Life sciences companies seeking protection for their biological products gain clarity on the submission procedures and standards of evaluation for reference product exclusivity requests. As the Food and Drug...more

FDA Announces "Purple Book"

The new phone book is here? No, but close. The Food and Drug Administration ("FDA") announced on Friday that it has published its first listing of approved biologic drugs. The list will be supplemented with approved...more

FDA’s 'Purple Book' for Biologics—Patents Not Included

This past week, the Food and Drug Administration (FDA) announced the creation of the “Purple Book,” which will list all biological products, including any biosimilar and interchangeable biological products, licensed by the...more

What’s In a Name? The Value of Pharmaceutical & Biologic Branding

September 2014 marks 30 years since the Hatch-Waxman Amendments (Hatch-Waxman) to the Food, Drug, and Cosmetic Act (FD&C Act) introduced generics as we know them. Hatch- Waxman strove to offer consumers the benefits of “rapid...more

FDA Releases Guidelines for 12-Year Period of Reference Product Exclusivity for Section 351(a) Biologics

The U.S. Food and Drug Administration (“FDA”) has released its latest “Guidance for Industry” regarding the FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which established an...more

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act

Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more

FDA Accepts First Biosimilar Application under New Approval Pathway

July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

FDA Issues Draft Guidance Relating to Distribution of New Risk Information for Approved Drugs and Biologics and Grants Two Citizen...

On June 6, 2014, the Food and Drug Administration (“FDA”) issued two documents that reflect the agency’s ongoing effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical...more

CMS To Publish Financial Relationships Between Physicians and Drug Manufacturers Beginning September 2014

Beginning in September 2014, the Centers for Medicare and Medicaid Services (“CMS”) will publish a list of all payments and transfers of value paid by drug manufacturers to physicians and teaching hospitals on a publicly...more

House and Senate Bills Would Provide Incentive for Repurposing Old Biologics

Last month, Sen. Richard Blumenthal (D-CT) and Rep. Joaquin Castro (D-TX) introduced legislation in the Senate and House, respectively, that would extend the term of certain patents claiming a method of using a biological...more

Pennsylvania Bio State Official of the Year

Rep. Warren Kampf (R-Chester) has been named State Official of the Year by Pennsylvania Bio. The award recognizes an official from Pennsylvania who has distinguished themselves in the bioscience industry. The annual recipient...more

The State of Vaccines Under the USPTO 101 Guidelines

In his State of the Union Address given on January 28, 2014, President Obama recognized the need for continued and increased investment in new technologies, including technologies specific to the biological and pharmaceutical...more

Notifications and Names: FTC Workshop Explores Effect of State Legislation and Naming Conventions on Follow-On Biologic...

Biologic medicines represent some of the most significant—both clinically and financially— pharmaceutical products in the United States today. Biologics have had remarkable success in the treatment of patients with many...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

FDA Publishes New Guidance on Letters from Manufacturers to Health Care Providers

The Food and Drug Administration (FDA) issued a new guidance document on Dear Health Care Provider (DHCP) letters, titled “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” DHCP...more

FDA Issues Draft Guidance Addressing Postmarket Submission Requirements for Internet-based Promotional Materials

On January 14, 2014, the U.S. Food and Drug Administration (Agency) published a long-awaited draft guidance entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for...more

FDA Issues Final Guidance Regarding Dear Health Care Provider (DHCP) Letters

Recommendations are Intended to Improve the Communication of Important New or Updated Safety Information for Prescription Drugs and Biological Products - On January 23, 2014, the Food and Drug Administration (FDA)...more

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