Biologics

News & Analysis as of

Health Canada releases revised guidance on the submission requirements for biosimilar biologic drugs

On December 2, 2016, Health Canada released the revised Guidance Document Information and Submission Requirements for Biosimilar Biologic Drugs. The Guidance is intended to assist biosimilar companies to navigate the...more

Regulatory News Roundup

The following are some noteworthy news stories on the regulatory front: ..The FDA shared best practices for biosimilar development. ..The EMA okayed a combination of insulin glargine and lixisenatide for treatment...more

Basics of the BPCIA

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Isto Holdings Acquires Arteriocyte To Form Isto Biologics

Isto Holdings, the parent company of Isto Technologies, has acquired Massachusetts based Arteriocyte Medical Systems Inc. and the two companies will be combined under the name Isto Biologics under the current CEO of Isto...more

U.S. Biosimilars Pathway Under Trump

This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception. Two of Trump’s stated policies...more

CETA Implementation in Canada - Implications of Bill C-30 on the Pharmaceutical Industry

Bill C-30 presents significant changes to Canada’s pharmaceutical landscape by introducing supplementary protection for pharmaceutical products and proposing substantial modifications to the Patented Medicines (Notice of...more

Pfizer to Lower Price of Enbrel in Ireland

The Irish Times reports that Pfizer will be cutting the price of Enbrel® (etanercept) on November 1st. Pfizer is cutting its price to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines (the...more

Catalent Biosimilars Manufacturing Update

Yesterday, Catalent Pharma Solutions announced that it has broken ground for a 22,000 square foot extension of its biologics manufacturing facility in Madison, Wisconsin. According to the press release, following completion...more

New Results Presented at ESMO: Merck’s Keytruda® Has Potential to be Used as First-Line Therapy for Non-Small Cell Lung Cancer

At yesterday’s European Society for Medical Oncology (ESMO) meeting, Merck Sharp & Dohme Corp. announced positive data from two studies regarding its Keytruda ® (pembrolizumab) biologic. According to Merck’s press release,...more

FDA Finalizes Rule Governing Establishment Registration and Listing for Human Drugs

On August 31, 2016, the US Food and Drug Administration published “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License...more

FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategy (REMS) Determinations

On September 21, 2016, the US Food and Drug Administration (FDA) issued Draft Guidance for Industry: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary, which is intended to clarify how the FDA...more

Four Years of IPRs: Lessons from Proceedings for the Cabilly II Patent

It has been four years since the first inter partes review proceedings were filed in the United States. The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the...more

Amgen’s Federal Circuit Appeal: the Importance of Manufacturing Information to Biosimilar Litigation

Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction. The appeal presents an important question for biosimilar...more

“Cabilly” and Other Foundational Patents in Biologic Drug Production

As we previously reported, over the past year several petitions requesting Inter Partes Review (IPR) of patents that claim foundational inventions for biologic drug production were filed. Here we discuss the scope of two of...more

CIMZIA Does Not Infringe Yeda’s Monoclonal Antibody Patent

In UCB, Inc. v. Yeda Research and Development Co., the Federal Circuit affirmed the determination by the District Court for the Eastern District of Virginia that UCB, Inc.’s Cimzia® (certolizumab pegol), a biologic medicine...more

Hospira Files an IPR Petition Challenging Genentech’s Bevacizumab Patent

On September 9, 2016, Hospira filed a petition for an IPR of U.S. Patent No. 7,622,115, owned by Genentech. The ‘115 patent claims methods of treating various cancers with bevacizumab, which is marketed by Genentech under...more

Express Scripts Announces New Program for Biologics

On Thursday, September 8, Express Scripts introduced its Inflammatory Conditions Care Value Program, which it says is a “comprehensive approach to control costs and improve care for people with inflammatory conditions like...more

FDA Call For Comments on Off-Label Communications

The FDA has announced a 2-day public hearing related to communications by manufacturers, packers, and distributors, regarding, in part, drugs licensed as biological products. There will be a particular focus on communications...more

US Biosimilar Pathway Update

Six years after the biosimilar pathway was enacted into law, FDA has approved three biosimilars for marketing in the US. Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, was the first biosimilar to be approved. Zarxio, a...more

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

BPCIA 180-Day Notice of Intent to Market a Biosimilar Is Required, Enforceable by Injunction

In an opinion that details many intricacies of both the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and related portions of the Patent Act, the US Court of Appeals for the Federal Circuit affirmed a...more

Enbrel Biosimilar Approved in US But Enjoined For Now

On August 30 FDA approved Sandoz Inc.’s biosimilar of Enbrel (etanercept), Amgen Inc.’s blockbuster biologic for treatment of moderate to severe rheumatoid arthritis and a number of other autoimmune conditions. The...more

A legal look at Patent Trial and Appeal Board decisions and trends: PTAB Statistics - Then and Now

The Inter Partes Review (IPR) and Covered Business Method (CBM) procedures were enacted on September 16, 2012. Since then, the PTAB has released data on a monthly basis to illustrate the trends in the various petitions and...more

JHU: Preliminary Evidence Supports Similarity of TNF-alpha Biosimilars To Reference Products

In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an...more

Coherus Submits 351(K) BLA Application to FDA for Pegfilgrastim Biosimilar

Coherus Biosciences, Inc. announced submission to the FDA of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. Pegfilgrastim is used to prevent or treat neutropenia, a...more

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