Beyond IP Protection: New Tactics Blocking Generic/Biosimilar Market Access
Beyond IP Protection: New Tactics Blocking Generic/Biosimilar Market Access

There is perpetual tension between competition and exclusivity.  Competition supports multisource supply.  Exclusivity requires protection for a single source.  Both have bearing on access to medicines.  Competition ensures access, while exclusivity denies access.  This tension was heightened during the negotiations on the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs), as developed countries, egged on by Big Pharma, pushed for higher intellectual property rights protection.

  • Can New York City Lead In Life Sciences?
    Can New York City Lead In Life Sciences?

    New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.

  • Can Biosimilars Increase The Profitability Of Generics Manufacturers?
    Can Biosimilars Increase The Profitability Of Generics Manufacturers?

    Generic drug prices are falling. For confirmation, look no further than the recent earnings reports from generic manufacturers and pharmaceutical wholesalers whose profits from distributing generic pharmaceuticals are also declining.

  • 5 Rules For Managing Relationships With Your CROs And Other Vendors In Clinical Trials
    5 Rules For Managing Relationships With Your CROs And Other Vendors In Clinical Trials

    Clinical research is becoming more and more complex due to many factors, including increased regulations, competition for patients, and cost of conducting clinical trials.  Most of the smaller pharmaceutical and biotech companies (sponsors) do not have the workforce to provide proper oversight of a clinical trial.  This forces companies to outsource much, if not all, of the trial oversight to contract research organizations (CROs) and service providers (vendors). 

  • The Evolving Landscape Of Biosimilar Risk Management Programs
    The Evolving Landscape Of Biosimilar Risk Management Programs

    In a presentation at the 2017 World Biosimilars Congress, Asif Mahmood, disease area safety and strategy lead at Pfizer, shed some light on global risk management strategies and the challenges of launching these programs.

  • How Biosimilar Companies Can Survive An Uncertain Future
    How Biosimilar Companies Can Survive An Uncertain Future

    In this final installment of a three-part series, managing directors Jonathan Kfoury and Ricardo Brau of L.E.K. Consulting share their perspectives on six biosimilar company archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future.

  • The Evolution Of Russia’s Biosimilar Regulatory Pathway
    The Evolution Of Russia’s Biosimilar Regulatory Pathway

    In a recent article, I discussed the market opportunities and reimbursement system in Russia. But in addition to this snapshot of the market, my conversation with BIOCAD's Roman Ivanov highlighted how the Russian biosimilar regulatory system was established, as well as the challenges BIOCAD has faced during it evolution.

  • Brexit & The Biopharma Industry: 3 Important Developments To Watch
    Brexit & The Biopharma Industry: 3 Important Developments To Watch

    There have been considerable updates in the Brexit situation since April 2017, including, the surprising result of the U.K. general election. If anything, news regarding Brexit and the biopharma industry has started to heat up in recent months, and there have been a number of relevant developments that manufacturers must keep their eye on.

  • Real-World Evidence: Lessons Learned From The ADAPTABLE Trial
    Real-World Evidence: Lessons Learned From The ADAPTABLE Trial

    Real-world evidence is a hot topic in clinical research right now.  But too often, the massive amounts of data now available from electronic medical records used in routine medical practice are being considered to be clinical evidence to support medical decision making. However, the process of transforming these large data sources into actionable evidence that can change clinical practice is a complicated but important endeavor.

  • Amgen v. Hospira: The Federal Circuit’s Latest On The Biosimilar Patent Dance
    Amgen v. Hospira: The Federal Circuit’s Latest On The Biosimilar Patent Dance

    In the Amgen v. Hospira decision, issued on Aug. 10, 2017, the U.S. Court of Appeals for the Federal Circuit gave a little more ammunition back to the biologics manufacturers (though on its face, it was a loss for Amgen), opining that the “could reasonably be asserted” language in the statute allows a biologics sponsor to initially include in the list any patent that it believes in good faith “could” reasonably be asserted, even if the belief is mistaken.

More Biosimilar editorial...

BIOSIMILAR INSIGHTS

  • Cross Flow Filtration Method Handbook

    This handbook gives a general introduction to the principles and applications of cross flow filtration using systems and filters from GE.

  • Optimizing the Flexural Strength of Bioprocess Film

    This poster focuses on how the resin selection and architecture of a bioprocess film can be optimized to maintain critical performance attributes, such as container integrity and gas barrier properties, under the significant forces during bulk liquid transportation and WAVE Bioreactor™ system applications.

  • CDMO Horror Stories And How To Avoid Them

    Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.

  • The Extreme Costs Of A Bioburden Incident - Infographic

    Apart from the potentially tragic impact on patients, the economic consequences of a batch failure are enormous. For the mAb blockbusters, a month production stop can result in lost revenues of up to 1 billion dollars and a typical QA investigation could cost $20,000.  Thankfully, there are solutions for decreasing the risks.  Download this Infographic on the financial impact of a bioburden incident and ways to reduce said impact.

  • Insights And Tips When Addressing Bioburden Challenges

    This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

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TRAINING COURSES

Biosimilars and Biobetters September 27 - 28, 2017
London
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Organizational Strategies for Reducing Human Error in GMP Environments October 3, 2017
1:00 - 2:30 PM EDT, Online training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template October 5, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
The Importance of Packaging and Labeling in Pharmaceutical Product Development October 12, 2017
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 – Includes Bonus handouts
How to Write SOPs That are GCP Compliant and Implementable October 17, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Best Practices in CMC Dossier Preparation – Facing Tough Challenges October 19, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
The Investigational New Drug (IND) Submission - Tips to Win the First Time October 24, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Biosimilars Conference October 24 - 25, 2017
Bethesda,, MD
More Upcoming Courses
Anna Rose Welch article header

 EVENTS

Biosimilars and Biobetters September 27 - 28, 2017
London
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Organizational Strategies for Reducing Human Error in GMP Environments October 3, 2017
1:00 - 2:30 PM EDT, Online training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template October 5, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
The Importance of Packaging and Labeling in Pharmaceutical Product Development October 12, 2017
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 – Includes Bonus handouts

LIFE SCIENCE EVENTS

Biosimilars and Biobetters September 27 - 28, 2017
London
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Organizational Strategies for Reducing Human Error in GMP Environments October 3, 2017
1:00 - 2:30 PM EDT, Online training
More Events...

LIFE SCIENCE INDUSTRY EVENTS

Biosimilars and Biobetters September 27 - 28, 2017
London
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Organizational Strategies for Reducing Human Error in GMP Environments October 3, 2017
1:00 - 2:30 PM EDT, Online training
More Industry Events

ABOUT BIOSIMILAR DEVELOPMENT

Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property.

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