All Clarivate Analytics websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

/images/Cortellis_Flagship_Logo_TM_RGB_Color.png
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Artificial intelligence
    • Coronavirus
    • Diagnosing and tracking COVID-19
    • Drugs to Watch 2020
    • The next pandemic
    • Premium reports
      • BioWorld Financings Reports
      • Disease Forecast Reports

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, March 5, 2021
Home » Blogs » BioWorld Perspectives » It’s How You Look at the Vial

BioWorld Perspectives
BioWorld Perspectives RSS FeedRSS

BioWorld / Oncology / Biosimilar

It’s How You Look at the Vial

Oct. 1, 2013
By Mari Serebrov
No Comments

blog 10-1-13What’s in a biosimilar name? That depends on whether the vial is half empty or half full.

Seeing it as half full, many generic makers focus on the similarities between a follow-on and its reference biologic. Because of those similarities, they say biosimilars and their reference product should share the same international nonproprietary name (INN) – as is the practice with traditional generic drugs. That’s the argument the Generic Pharmaceutical Association (GPhA) made in the citizen petition it submitted to the FDA earlier this month.

Used to cashing in on the success of a small molecule brand drug by sharing its INN and through automatic substitution with little marketing effort, generic makers frame their argument as one of access to cheaper biologics. The more biosimilars are seen as the same as the innovator drug, the easier their job will be in selling them to the market at discounted prices.

On the other side of the debate are brand makers, joined by several patient advocates, who see the vial as half empty. In demanding unique names for each biosimilar, they highlight the differences between biosimilars and the innovator biologic.

Used to having a corner on the biologic market, the innovators, some of whom are developing their own biosimilars, frame the argument as one of safety. The more patients and prescribers are aware of the differences and exactly which version of a drug is being dispensed, the easier it will be to track adverse events – and perhaps maintain the innovator’s marketing edge.

Either way, the truth is likely found somewhere in the middle of the vial.

As with all follow-on, generic and me-too drugs, there are both similarities and differences. But given the complexity of some biologics, there are questions patients will want answered before they trust their health to a new version of a biologic that’s working for them. Exactly how similar is the “highly similar” standard set by the FDA for biosimilars? Is it simply a matter of “we’ll know it when we see it”?

And given the potential differences, no matter how slight, the FDA’s stance that biosimilars don’t need to demonstrate safety also raises a few questions. What is the certainty that minor manufacturing differences won’t become a major clinical difference in a subset of patients, especially if the mechanism of the innovator biologic isn’t fully understood? Short of massive clinical trials, how can drugmakers demonstrate that those differences are truly minor? And, contrary to the FDA’s current position, should biosimilar makers have to demonstrate the safety of their products?

Patients don’t care if the vial is half full or half empty. They want to know that the biologic they’re given is as safe and effective as the one they’ve used before.

You must login or register in order to post a comment.

Report Abusive Comment

Popular Stories

  • Free access to BioWorld coronavirus articles

    BioWorld

    The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak. Note that we have added three critical tables which are...

  • Today's news in brief

    BioWorld
    BioWorld briefs for March 4.
  • Gloved hand places sample tubes in PCR system

    COVID-19 test makers are adapting for variants

    BioWorld MedTech
    As COVID-19 variants have emerged, so have questions about the effectiveness of tests for infection. While the risk of mutations significantly limiting their...
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech's briefs for March 4.
  • Celltrion-Regkirona-2-9

    Celltrion wins first conditional Korean approval for COVID-19 antibody Regkirona

    BioWorld
    HONG KONG – Celltrion Inc. has received conditional marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its anti-COVID-19 monoclonal...
cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • About
    • Archives
    • Today's news
    • Search BioWorld Science
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
A Clarivate Analytic solution. Link to Clarivate website.
Follow Us

Copyright ©2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing