Pharma Forum Dialogues

New York Pharma Forum Inc.

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Posted by New York Pharma Forum Inc. on Apr 10, 2017 1:38:08 PM

By: Nao Takada and Eric W. DittmanPaul Hastings LLP



イノベーション法(Biologics Price Competition and Innovation Act: BPCIA)を制定した。 従来、申請者はFDAにその製品の安全性および有効性を実証する臨床データを提供し、販売承認の許可申請であるバイオロジック・ライセンス・アプリケーション( Biologics License Application: BLA)を提出していた。 BPCIAの元の簡略化された経路では、簡略化されたBLA(「aBLA」)の申請者は、その製品が「バイオシミラー」または「交換可能[1] であることを示す情報を代わりに提出する。既に承認されている参照製品のスポンサー(Reference Product Sponsor: RPS)は、後続のバイオシミラー製品に対して特許保護の有無にかかわらず、最長12年の独占期間を得る。

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Topics: biosimilars, Supreme Court, BPCIA

The First Supreme Court Review of a Biosimilar Case

Posted by New York Pharma Forum Inc. on Apr 10, 2017 1:34:48 PM

By: Nao Takada and Eric W. DittmanPaul Hastings LLP

Read in Japanese


In 2010, Congress enacted the Biologics Price Competition and Innovation Act (“BPCIA”) as an attempt to balance innovation and competition in the biopharmaceutical market.  Traditionally, an applicant filed a Biologics License Application (“BLA”) providing the FDA with clinical data demonstrating the safety and efficacy of its product.  Through the BPCIA abbreviated pathway, an abbreviated Biologics License Application (“aBLA”) applicant instead submits information demonstrating that its product is “biosimilar” or “interchangeable.”[1]  The sponsor of an approved reference product, called a “reference product sponsor” or “RPS,” receives up to 12 years of exclusivity against follow-on biosimilar products, regardless of patent protection.

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Topics: biosimilars, Supreme Court, BPCIA

The Roots of Disruptive Innovation: Healthcare and Beyond

Posted by New York Pharma Forum Inc. on Aug 25, 2015 2:14:54 PM

What do four startups in the pharmaceutical, financial services, online retail, and solar lighting industries have in common? A July New York Pharma Forum program explored the “Roots of Disruptive Innovation,” the common element that brought together four successful entrepreneurs in very different fields to discuss their innovative products’ origins.

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Topics: entrepreneur, innovation, healthcare

Court Decision Clarifies Hatch-Waxman Data Exclusivity

Posted by New York Pharma Forum Inc. on Jul 30, 2015 2:00:00 PM

By: Clark G. Sullivan and Sujatha VathyamTroutman Sanders LLP

A pharmaceutical patent lawsuit against the Food and Drug Administration (“FDA”) earlier this year has clarified when 3-year Hatch-Waxman data exclusivity will prevent the United States Food and Drug Administration (“FDA”) from approving an application filed under section 505(b)(2) of the Food Drug and Cosmetic Act (the “FD&C Act”). In the case, Veloxis Pharmaceuticals, Inc. v. FDA, a United States District Court held that reliance on an earlier approval was not necessary for three year data exclusivity to delay the later filed 505(b)(2) application. Exclusivity arose solely because the later application was for the same drug as the earlier approval and would be approved for the same conditions of use.

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Topics: Hatch-Waxman Litigation, patent law, FDA guidance

Softgel Formulations - An Elegant Vehicle for Commercial Success

Posted by New York Pharma Forum Inc. on May 4, 2015 10:22:00 AM

By: Jyoti Sharma, Content Marketing Specialist, Catalent Pharma Solutions

The results from a recent drug delivery landscape survey1 confirm the key challenges faced by formulation scientists and R&D managers. Safety, efficacy, bioavailability and solubility issues dominated as the most significant factors in developing drug formulations. As per BCS classification, ~70% of new chemical entities (NCE) are class II or IV, either poorly soluble in water, have low cell permeability or both. It takes tremendous effort and investment for pharmaceutical companies to come up with NCEs which potentially can be commercialized into blockbuster drugs. A drug delivery system that can overcome the solubility and bioavailability challenges can result in increased probability of a commercially successful drug. 

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Double Your Dose of Social Media and Call Me in the Morning

Posted by New York Pharma Forum Inc. on Apr 16, 2015 10:00:52 PM

By: Kathy Cripps, President of the PR Council (@PRCouncil

It’s no secret that consumers are social beings, so why should patients be treated any differently? Research has found that the average American goes to the doctor three times during the course of a year, but spends 52 hours online searching for health information. It’s not just from a computer either; 52 percent of smartphone users have looked up health or medical information from their mobile devices1.  Americans want answers fast and head straight to online news outlets, social media channels, blogs, Wikipedia, pharmaceutical company websites, and everything in between. 

Yet a recent Forbes article observes, “Among the 50 largest [pharmaceutical] companies, half still do not use social media to engage consumers or patients,” and only 10 of these 50 have made use of Twitter, YouTube, and Facebook, the top three social media channels.2  

Why have so few pharmaceutical companies broken through using social media? Clearly companies remain concerned about running afoul of FDA regulators, and for that reason have not yet fully embraced new channels. When the FDA released long-awaited guidelines about the communication of health information via social media, it took a fairly restrictive stance, requiring that companies communicate information about risks and benefits in any social media message.

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New York Pharma Forum’s Top 3 Most-Read Blog Posts of 2014

Posted by New York Pharma Forum Inc. on Mar 24, 2015 7:16:00 PM


Pharma industry leaders share their expertise on Pharma Forum Dialogues, the blog launched by New York Pharma Forum in 2014.  Here are the top 3 most-read blog posts of 2014.

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NY Attorney General Sues Forest Laboratories for “Product Hopping”

Posted by New York Pharma Forum Inc. on Nov 12, 2014 10:46:00 PM

Antitrust accusations based on so-called “product hopping” continue to make the headlines, most recently after the Attorney General for the State of New York (the “AG”) brought an antitrust lawsuit against Actavis, PLC and its subsidiary Forest Laboratories, LLC (collectively “Forest”) based on their marketing plans for Alzheimer’s drug Namenda®.  “Product hopping” is a term used by the United States Federal Trade Commission (“FTC”) to refer to the practice by some pharmaceutical companies of withdrawing one version of a drug in favor of another, as generic competition for the first version approaches.

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Two FDA Citizen Petitions Granted Regarding Manufacturer Speech

Posted by New York Pharma Forum Inc. on Aug 1, 2014 3:08:00 PM

By Al Cacozza and Sarah Blankstein, Ropes & Gray

On June 6, 2014, the Food and Drug Administration (“FDA”) issued a response granting the two pending FDA citizen petitions[1] filed by members of the Medical Information Working Group (“MIWG”), an ad hoc coalition of drug and device manufacturers to which Ropes & Gray LLP serves as one of the outside counsel. This response reflects the agency’s on-going effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical information to health care professionals (“HCPs”). This post summarizes the key aspects and implications of that response.

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Topics: FDA guidance

FDA Releases Draft Guidance on New Risk Information for Approved Drugs

Posted by New York Pharma Forum Inc. on Jul 16, 2014 5:07:00 PM

By Al Cacozza and Sarah Blankstein, Ropes & Gray

On June 6, 2014, the Food and Drug Administration (“FDA”) issued a draft guidance on new risk information for approved drugs. The document is entitled “Guidance for Industry: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices.”  This post summarizes the key aspects of that document.

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Topics: FDA guidance