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  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
      • Clinical Trials (GCP)
      • Manufacturing
      • Medical Devices
      • Regulatory
      • R&D
      • Leadership & Training
    • eLearning
      • Clinical Pathways
      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
    • LSTI Learning Library
    • Training Voucher Packages
    • Checkout
  • Custom Training
    • Live Training
    • Elearning Solutions
    • LSTI Corporate Learning Library
    • CRA Academy
  • Articles & Resources
  • About LSTI
    • LSTI Leadership
    • LSTI Instructors
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Partnering With Insurers To Improve Biosimilar Access In The U.S.

Drug developers have found a powerful ally in their campaign to advance biosimilar adoption in the U.S. — the nation’s health insurance providers. Insurers are keen to drive down the price of reference biologics, and they view biosimilars as an important way to accomplish that goal.

Posted in: FDA, Manufacturing,
Tags: biologics, drug, insurance, l, legal,
6 Public Policy Changes To Ensure A Competitive Biosimilar Market

Prescription drug spending increases — fueled by high launch prices for new therapies and price increases for existing brand-name drugs — are contributing to unsustainable healthcare cost growth across the country. In addition to straining the healthcare system overall, high drug prices also place financial burdens on patients who rely on prescription medicines to treat and manage serious and chronic medical conditions.

Posted in: FDA, Manufacturing,
Tags: biologics, biosimilar drugs, drug spending, durg prices, prescription drug,
Patent Eligibility Of Biologic & Biosimilar Patents — A Primer

To be entitled to a patent, an invention must satisfy a number of patentability requirements, including the “patent eligibility” requirement under 35 U.S.C. § 101. Part 1 and Part 2 of this three-part series reviewed the origin and history of the patent-eligibility requirement and jurisprudence and how the U.S. Supreme Court’s decisions since Mayo Collaborative Services v. Prometheus Labs, Inc. significantly raised the patent-eligibility bar, and examined the impact of Mayo on life sciences patent litigation in lower courts.

Posted in: Manufacturing,
Tags: biologics, biosimilar, drug patents, eligibility,
dancers
Amgen v. Hospira: The Federal Circuit’s Latest On The Biosimilar Patent Dance

“Patent dance” refers to the elaborate exchange of patent information between a biosimilar applicant and a biologics sponsor under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. It is intended to have the parties resolve any patent disputes expeditiously, preferably before the launch of the biosimilar product. Under the Act, within 20 days of FDA’s acceptation of an abbreviated biologics license application (aBLA), the biosimilar applicant “shall provide to the reference product sponsor a copy of the application … and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” This starts the dance.

Posted in: Manufacturing,
Tags: biologics, biosimilar,
Tend
The U.S. Biosimilar Market: Where Is It Today, And Where Is It Going?

The U.S. biosimilar market is relatively new. It took another two years for the FDA to issue the first draft guidelines for developing and registering a biosimilar in the United States, and another three years until the first biosimilar was approved.

Posted in: FDA,
Tags: biologics, biosimilar developer, biosimilars,
Surveying
Chinese & Indian GMP Biologics Exports — Surveying The Current Landscape

India and China represent nearly 40 percent of the world’s population, so their domestic markets for biologics alone represent a remarkable opportunity. However, currently, the opportunities for sales of biological therapeutics remain in more developed countries.

Posted in: FDA, Manufacturing,
Tags: biologics, biopharmaceutical, biotechnology, GMP, R&D,

Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
  • How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer
  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

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About Us

The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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  • 101 Gibraltar Road, Suite 100 Horsham, PA 19044
  • 215-675-1800 (option 3)
  • info@lifesciencetraininginstitute.com

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  • Clinical Trials (GCP Training)
  • Coronavirus / COVID-19
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