Why You Shouldn’t Worry About Biosimilar Retail Pharmacy Uptake
Why You Shouldn’t Worry About Biosimilar Retail Pharmacy Uptake

In the first of this two-part article, I highlighted the current, cautious biosimilar climate in one IDN and some of the challenges hindering uptake. But I was pleasantly surprised by the confidence Michael Jacobs, senior director of health and wellness at Walmart, had about the positive impact the retail pharmacy model could have on biosimilars in the upcoming years. 

  • What Thailand Revealed About U.S. Pharma R&D
    What Thailand Revealed About U.S. Pharma R&D

    A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.

  • Enforcement & Regulatory Responses To The Pharmacy Benefit Manager Debate
    Enforcement & Regulatory Responses To The Pharmacy Benefit Manager Debate

    The first part of this article introduced pharmacy benefit managers (PBMs) and their business model and explored the monopolization concerns in this market. The focus now turns to state and federal actions regarding PBMs.

  • What To Know About Thailand’s Life Sciences Industry
    What To Know About Thailand’s Life Sciences Industry

    About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.

  • Engaging A Life Science Consultant: Common Pitfalls & Best Practices
    Engaging A Life Science Consultant: Common Pitfalls & Best Practices

    This article summarizes insights gleaned from interviews with multiple consultants, each of whom has at least 25 years’ experience in the life sciences space — and from conversations with the life science companies who hire such consultants to ensure that their systems meet the product quality attribute/specification requirements mandated by their respective regulators.

  • The Rules Of Engagement For Biosimilar Legal Battles
    The Rules Of Engagement For Biosimilar Legal Battles

    These are formative days for biosimilar developers in the U.S. courts. Last month, the biosimilar market witnessed its first legal settlement, between Mylan and Genentech for trastuzumab, and further settlements are sure to follow. On April 26, the Supreme Court began hearing the case between Amgen and Sandoz regarding the infamous “patent dance.” The Court’s ruling (expected in July) will have significant ramifications on how quickly new biosimilars reach the market.

  • Political Uncertainty Emphasizes Need For More Efficient Biosimilar Development
    Political Uncertainty Emphasizes Need For More Efficient Biosimilar Development

    It’s unlikely biosimilar applications containing only analytical and preclinical data will meet the FDA’s demands for totality of the evidence within the next few years. However, a changing political climate urging quicker development and lower drug prices has only intensified the discussion within the biosimilar industry about developmental efficiency.

  • Surveying The Current Legal Landscape For Biosimilars
    Surveying The Current Legal Landscape For Biosimilars

    These are formative days for biosimilar developers in the U.S. courts. Last month, the biosimilar market witnessed its first legal settlement, between Mylan and Genentech for trastuzumab, and further settlements are sure to follow. On April 26, the Supreme Court began hearing the case between Amgen and Sandoz regarding the infamous “patent dance.” The Court’s ruling (expected in July) will have significant ramifications on how quickly new biosimilars reach the market.

  • What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations?
    What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations?

    This article presents the most recent GMP inspection data from CDER and MHRA (Medicines and Healthcare Products Regulatory Agency).  The CDER data and the MHRA data come from GMP inspections conducted in 2016.

  • The BBCIC: Ushering In The Age Of Biosimilar Post-Marketing Surveillance
    The BBCIC: Ushering In The Age Of Biosimilar Post-Marketing Surveillance

    The BBCIC is in the midst of undertaking one of the biggest challenges facing the industry: biosimilar post-marketing surveillance. Despite its young, two-year tenure, the BBCIC has set several key goals for the year ahead to ensure science, not anecdotal reporting, informs all stakeholders about biosimilar performance.

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BIOSIMILAR INSIGHTS

  • Lonza and Atvio Biotech Seek New Technologies To Advance Personalized Medicine

    Despite their potential to increase the efficiency of the healthcare system, autologous cell therapy treatments present significant challenges to most companies when it comes to development and manufacturing. Innovators across the industry who want to see personalized medicine, such as autologous cell therapies, reach its full potential are focusing on developing technology that can create a realistic business model for these treatments.

  • Will Asia Go Big In Biosimilars Adoption And Manufacturing?

    Since 1984 when U.S. regulations favoring adoption of generics were enacted, the global generics market has grown to account for roughly 38% of global pharmaceutical spending and this portion is expected to increase to 43% in the next five years.1 Will biosimilars follow the generics trajectory in the next few decades?

  • Biosimilars Producer, Alvotech, Finds Opportunities In Iceland

    In June 2016, Alvotech opened their new biosimilar manufacturing facility in Reykjavik, Iceland, using best of breed solutions from leading Life Science vendors.  The key directive for Alvotech was to create a flexible, agile process which could adapt and be used for any conceivable process.  The result:  A high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System. 

  • Single-Use Solutions For Cell Culture Scale-Up And Technology Transfer

    A question and answer session with Barbara Paldus, Ph.D., Vice President and General Manager Finesse, part of Thermo Fisher Scientific

  • Bioburden Sources You Might Have Missed

    A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.

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TRAINING COURSES

Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner June 7, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
ACI’s 8th Annual Summit on Biosimilars June 12 - 14, 2017
New York, NY
Cell Therapy: Process Design Considerations To Support Commercialization June 13, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Environmental Monitoring (EM) – Establishing and Improving Programs Using a Risk-based Approach June 14, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Organizational Strategies for Reducing Human Error in GMP Environments June 20, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
How To Establish The Number of Runs Required For Process Validation June 28, 2017
1:00 - 2:00 PM EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum July 10, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
CRO Oversight Post ICH GCP E6 (R2) Addendum July 10, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Conducting an Effective GCP Audit of a CRO-Managed Ongoing Study: Tips and Suggestions July 11, 2017
1:00 - 2:30 PM EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Manufacturing & Laboratory Equipment Qualification – Ensuring Bullet-Proof Results July 12, 2017
1:00 - 2:00 PM EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
More Upcoming Courses
Anna Rose Welch article header

 EVENTS

Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner June 7, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
ACI’s 8th Annual Summit on Biosimilars June 12 - 14, 2017
New York, NY
Cell Therapy: Process Design Considerations To Support Commercialization June 13, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Environmental Monitoring (EM) – Establishing and Improving Programs Using a Risk-based Approach June 14, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Organizational Strategies for Reducing Human Error in GMP Environments June 20, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!

LIFE SCIENCE EVENTS

Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner June 7, 2017
1pm-2:30pm EDT, Online Training
ACI’s 8th Annual Summit on Biosimilars June 12 - 14, 2017
New York, NY
Cell Therapy: Process Design Considerations To Support Commercialization June 13, 2017
1pm-2:30pm EDT, Online Training
Organizational Strategies for Reducing Human Error in GMP Environments June 20, 2017
1pm-2:30pm EDT, Online Training
More Events...

LIFE SCIENCE INDUSTRY EVENTS

Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner June 7, 2017
1pm-2:30pm EDT, Online Training
ACI’s 8th Annual Summit on Biosimilars June 12 - 14, 2017
New York, NY
Cell Therapy: Process Design Considerations To Support Commercialization June 13, 2017
1pm-2:30pm EDT, Online Training
Organizational Strategies for Reducing Human Error in GMP Environments June 20, 2017
1pm-2:30pm 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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