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 - Wednesday, March 3, 2021
Home » Blogs » BioWorld Perspectives » Biosimilar regulation: 1984 v. 2014

BioWorld Perspectives
BioWorld Perspectives RSS FeedRSS

BioWorld / Biosimilar / BLA

Biosimilar regulation: 1984 v. 2014

Feb. 19, 2014
By Mari Serebrov
No Comments

Biosimilars blogIt’s 1984. The year opens with the demise of Ma Bell, as the Bell System is broken into smaller, regional telephone companies. The idea is to end Ma’s nationwide monopoly, but the result is a handful of smaller monopolies since there still is no telephone competition.

The Soviet Union leads a boycott of the Summer Olympics being held in Los Angeles, presumably as payback for the U.S. boycott of the 1980 Moscow Games, which was, in turn, a response to the Soviet war in Afghanistan.

Even though Time named the computer the “Machine of the Year” two years ago, personal computers have yet to become a ubiquitous household necessity. And email and the Internet are technology trends still waiting to happen.

Congress passes the Hatch-Waxman Amendments, giving rise to generic drug competition. It will be more than a decade before the biologic license application is created. The concept of a biosimilar is unimaginable, given the state of the science and the complexity of biologics.

Fast forward 30 years.

Ma Bell is an all-but-forgotten memory. With the rise of the Internet, fiber optics and cell phones, telephone competition is rampant.

The Soviet Union is no more. Russia is hosting the Winter Games as the U.S. is trying to end its war in Afghanistan.

Clunky PCs have given way to laptops and tablets, which are everywhere. Meanwhile, texting and social media have pushed past email as the speedy communication of choice.

Thanks to Hatch-Waxman, generics account for more than 80 percent of prescription drugs dispensed at U.S. pharmacies. Despite the success of the 1984 act, Congress recognized it wouldn’t work for follow-on biologics. That’s why it laid out a new regulatory path for biosimilars in 2010.

As the first biosimilars move toward approval in the U.S., a deep divide is forming between drugmakers on how the follow-ons should be regulated within the framework of the Biologics Price Competition and Innovation Act. Some advocacy groups, trade associations and lawmakers pitch this divide as the same old struggle that greeted Hatch-Waxman – with greedy brand drugmakers out for every dollar they can wring from the health care system squaring off against altruistic generics that want only to make biologics as affordable as possible for the masses.

But the truth is that the biosimilar divide is one of vision. On one side are drugmakers developing biosimilars that see this as a unique market. Comprised of companies like Amgen Inc. that pioneered innovative biologics and those like Sandoz International GmbH that have made their name as giants in the generics realm, this group welcomes the opportunity to form a new market tailored to the challenges and promises biologics offer, while taking advantage of today’s technologies and pharmacovigilance capabilities.

Mired in the past, the other group consists of generic companies that don’t want to have to change to compete in tomorrow’s biosimilars market. Instead, they cling to yesterday’s business models based on a 30-year-old regulatory scheme designed for small-molecule drugs.

Here’s another truth that often gets ignored: Experts are pretty much agreed that, given the cost of developing a biosimilar, the price discount is likely to be no more than 30 percent, at least initially. The visionary biosimilar developers like Hospira Inc. understand that they have to invest in communicating with physicians, patients and payers to build confidence in their follow-ons. But those generic companies pushing for automatic substitution with no notification to physicians hope to guarantee themselves the same discount without further investment.

It all comes down to recognizing the promise of a biosimilar while understanding that it is not a generic. Greg Howard, vice president for Conover Gould Strategic Communications and a spokesman for Actavis Inc., summed up the difference nicely for BioWorld: “A generic is to a biosimilar what chess is to 3-D chess.”

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 2.
  • 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 2.
  • 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