Biologics

News & Analysis as of

UK MHRA to develop quality standards for biological medicines

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines....more

Alert: FDA Maintains Assigned Unique Suffixes in Generic Names for Biologics

On January 12, 2017, the FDA issued its final guidance on generic naming for biological products submitted pursuant to 351(a) or (k) of the Public Health Service Act. The guidance is titled Nonproprietary Naming for...more

FDA Issues Guidance Regarding Interchangeability of Biosimilar and Biologic Drugs

On Tuesday, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This...more

Inherent Anticipation for Biotechnology Inventions

Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more

Supreme Court to Consider Biologics Price Competition and Innovation Act

On Friday, Jan. 13, the Supreme Court granted the appellant’s petition and the respondent’s cross-petition for a writ of certiorari in Sandoz Inc. v. Amgen Inc. This is the first time the Court will construe the Biologics...more

Supreme Court Grants Cert in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition in Amgen v. Sandoz, case nos. 15-1039 and 15-1195. The two cases were consolidated, and an hour was allotted for oral...more

FDA Issues Final Guidance Requiring Meaningless Suffixes for Biosimilar Names

Despite nearly universal opposition from both biosimilar makers and innovator companies, FDA has issued final guidance adopting its controversial August 2015 proposal for naming biologics. Under the guidance adopted by FDA,...more

RxIP Update - 2016 Year in Review

The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more

Breaking News: Court Grants Permanent Injunction Against Sale of Praluent® in AMGEN V. SANOFI/REGENERON

For the past few years, Amgen has been asserting patents in a litigation against Sanofi and Regeneron Pharmaceuticals in the District of Delaware to prevent them from selling Praluent® (alirocumab), a biologic that competes...more

EPO Stays Proceedings Over Patentability Of Plants And Animals

While the U.S. is still sorting out “natural products” jurisprudence under 35 USC § 101, the European Patent Office (EPO) is wrestling with the patentability of plants and animals, and has announced an immediate stay on all...more

When Time is Money

As the Biologics market is predicted to be a $250 billion market in the next few years, it is not surprising that parties embroiled in biosimilar litigation go to the mat. Both Apotex and Sandoz filed cert petitions this year...more

Rx IP Update - December 2016

Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

Biosimilars: Solicitor General Recommends Granting Certiorari in Amgen v. Sandoz

Responding to the Supreme Court’s request for its views, the Solicitor General recently recommended granting certiorari and reversing some of the Federal Circuit’s key holdings in Amgen v. Sandoz (Nos. 15-1039 & 15-1195)....more

Basaglar (Insulin Glargine Injection) Launches in US

Eli Lilly and Boehringer Ingelheim announced today that their insulin glargine injection product, Basaglar® (a follow-on biologic for Sanofi’s Lantus®), is now available by prescription in the U.S. Although Basaglar is...more

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

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