• How This Medicare Part D Proposal Gives Biosimilars Chance To Shine
    How This Medicare Part D Proposal Gives Biosimilars Chance To Shine

    Establishing new language requiring a portion of rebates to be passed on to consumers at the point-of-sale could bode well for biosimilar makers, and especially those that provide a competitive price.

  • Will EU Patent System Changes Speed Market Entry For Biosimilars?
    Will EU Patent System Changes Speed Market Entry For Biosimilars?

    In October 2017, the European Commission issued a consultation seeking input from the public regarding whether improvements can be made to the patent system. The goal is to achieve a balance between extension of patent protection and patent exemptions that make it easier to bring products to market in regulated industries. The commission specifically addressed the consultation to stakeholders in the biosimilar industry, among other regulated industries. The policy questions underlying patent extensions and research exemptions could have far-reaching impact on how quickly a biosimilar sponsor can get a product to market.

  • CMS’ Decision On Coding For Biosimilars: A Deeper Look
    CMS’ Decision On Coding For Biosimilars: A Deeper Look

    The November 2017 decision by CMS to change the coding practice for biosimilars in the United States is likely to have far-reaching consequences for these drugs, but will all downstream effects be positive? As the decision is applauded by various prescriber, patient, and industry groups, it is key to investigate the events that could ensue from the decision, and whether it will stimulate the U.S. biosimilar industry, which languishes behind that of other geographies.

  • The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers
    The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers

    Control of the Remicade and biosimilar market is being aggressively contested by Janssen, J&J, Celltrion, Hospira, and Pfizer. This article discusses the legal issues being decided in each of the federal court cases surrounding Remicade.

  • DIA Biosimilars Conference Reveals “More Questions Than Answers”
    DIA Biosimilars Conference Reveals “More Questions Than Answers”

    During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

  • Pfizer’s Cultural Evolution To “Tell The Biosimilar Story”
    Pfizer’s Cultural Evolution To “Tell The Biosimilar Story”

    Pfizer's Tracy Dianis presents a candid look into the cognitive and cultural transition that needed to occur in her own mindset, as well as within Pfizer, in order to embrace biosimilar development.

  • Biosimilar Regulatory Best Practices: Don’t Fear Exploration
    Biosimilar Regulatory Best Practices: Don’t Fear Exploration

    In the first of this two-part article, Sandoz's Cindy Cao shares lessons learned from working with the FDA and reveals that there is still a lot of room for exploration and innovation in biosimilar development.

  • How Can Biosimilars Remain Politically Relevant?
    How Can Biosimilars Remain Politically Relevant?

    What does the biosimilar industry need to do now to ensure it’s a relevant and central part of current and future healthcare reform?

  • What These Two Mottos Must Mean For The Biosimilar Industry
    What These Two Mottos Must Mean For The Biosimilar Industry

    I recently attended the Association for Accessible Medicines (AAM) Biosimilars Council’s Leading on Biosimilars conference.In addition to the many tidbits of knowledge I took away from this event, two terms kept resurfacing throughout the conference I feel are worth delving into more deeply.

  • 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.

  • Russia’s Biosimilar Market At A Glance
    Russia’s Biosimilar Market At A Glance

    After my discussion with BIOCAD's Roman Ivanov, it’s clear the Russian biosimilar market is a prime example of the positive impact biosimilars can have on a nation. However, Russia's biosimilar market has evolved quite differently than those of the EU and U.S.

  • Plant-Based Biosimilar Development Takes Root In Brazil
    Plant-Based Biosimilar Development Takes Root In Brazil

    In June 2017, Canadian company PlantForm announced it was beginning construction for a pilot biologics and biosimilar manufacturing facility in Brazil. Given Brazil’s ongoing efforts to establish a local biotechnology industry, I reached out to learn more about PlantForm’s progress in navigating the regulatory landscape to bring its biosimilars closer to market.

  • How To Handle The Impending Biosimilar Pipeline Boom
    How To Handle The Impending Biosimilar Pipeline Boom

    There is no cut-and-dried approach to launching a biosimilar globally. It comes down to having the right commercial model for the right product in the right channel in the right market.  But knowing what is “right” will be a particular stumbling block for many companies.

  • Building Thailand’s Biosimilar Industry From The Ground Up
    Building Thailand’s Biosimilar Industry From The Ground Up

    As the first of this two-part article revealed, the biosimilar market has undergone several revolutions since the release of the Thai FDA’s biosimilar guidelines in 2013. During our tour of Siam’s facilities, the company’s managing director, Songpon Deechongkit, Ph.D., shared the company’s history, overall biosimilar strategy, and some of the pros and cons of being the first and only biosimilar company in Thailand.

  • The Thai FDA’s Approach To Biologics And Biosimilars
    The Thai FDA’s Approach To Biologics And Biosimilars This article examines Thailand's history with biologics and biosimilars, as well as Siam Bioscience's perceptions of the current Thai FDA biologics and biosimilar regulations in relation to the U.S. and EU.
  • A Deep Dive Into Brazil’s Biosimilar PDPs
    A Deep Dive Into Brazil’s Biosimilar PDPs

    In terms of life sciences, Brazil is best known as a small molecule pharmaceutical market; some of the largest companies in Brazil are small molecule generics companies. But, in recent years, the country has identified the importance of establishing a biotechnology industry. Enter the productive development partnerships (PDPs). 

  • 5 Biosimilar Questions: The Payer Perspective (Part 2)
    5 Biosimilar Questions: The Payer Perspective (Part 2)

    In this article (the second of two parts), experts from a regional and national payer elaborate on some of their expectations for the market and how they — in partnership with companies — can encourage biosimilar acceptance.

  • 5 Biosimilar Questions: The Payer Perspective (Part 1)
    5 Biosimilar Questions: The Payer Perspective (Part 1)

    In the first of this two-part article, two experts from a regional and national payer reveal why they haven't exactly taken the hoped-for no-holds-barred approach to biosimilars.

  • The Importance Of Options In Biosimilar Litigation
    The Importance Of Options In Biosimilar Litigation

    A recent discussion amongst experts from Momenta, Eli Lilly, and Foley & Lardner highlighted the diversity of opinions surrounding Amgen v. Sandoz and other legal challenges in the space. But lurking underneath discussions of statutes and standards of evidence is biosimilar makers' desires for options to address the U.S.' rigid patent landscape.

  • How Congress Can Help Biosimilars Succeed
    How Congress Can Help Biosimilars Succeed

    In the third, most recent installment of The Atlantic’s biosimilar policy update, Vermont Representative Peter Welch homed in on several misperceptions and hesitations within Congress which are serving as a stumbling block to government-assisted cheaper prices, as well as the timely market entry of biosimilars.   

  • How Biosimilars Are Challenging The FDA Beyond The Science
    How Biosimilars Are Challenging The FDA Beyond The Science

    Listening to the diverse membership of the biosimilar industry speak at a number of conferences this past year has raised two questions about the FDA and the overall role it should play — both in citizens’ lives and within the industry.

  • Two Key Questions Tackled At 2017 World Biosimilar Congress
    Two Key Questions Tackled At 2017 World Biosimilar Congress

    There were two big questions that were addressed throughout the recent World Biosimilar Congress conference that both deepened my own knowledge of this space and/or called attention to topics that have been cropping up in other industry discussions.

  • 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. 

  • How Biosimilars Will Fare In Integrated Delivery Networks
    How Biosimilars Will Fare In Integrated Delivery Networks

    After hearing presentations by two experts working in an integrated delivery network (IDN) and a retail pharmacy setting, it’s clear each has a decidedly different stance on biosimilars: one is cautious, the other confident. In the first of this two-part article, I address the current, cautious biosimilar climate in one IDN and some of the challenges hindering uptake.

  • 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.

  • 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.

  • Why Interchangeability Won’t Be The “Silver Bullet” For Biosimilar Uptake
    Why Interchangeability Won’t Be The “Silver Bullet” For Biosimilar Uptake

    We’ve continued to see more data released emphasizing the safety of biosimilar switching abroad. However, as Merck KGaA Darmstadt Germany's Sue Naeyaert argues, these data alone are unlikely to be the silver bullet to greater biosimilar uptake. In an interview, Naeyaert shared her thoughts about how interchangeability in the U.S. will play out, as well as how biosimilar use could be incentivized in the fragmented American healthcare system.

  • What Biosimilar Companies Should Think About A 70 % Discount
    What Biosimilar Companies Should Think About A 70 % Discount

    Edric Engert, managing director of Abraxeolus Consulting (formerly of Teva), shares his opinions on where the biosimilar market is heading, how we can promote greater uptake within the U.S., and just how “genericized” the market can and will potentially become.  

  • 3 Notable Trends In Amgen’s 2017 Biosimilar Report
    3 Notable Trends In Amgen’s 2017 Biosimilar Report

    The 2017 Amgen "Trends in Biosimilars" report called attention to a few trends that align with what I’ve been observing within the industry that manufacturers, payers, and prescribers should expect for the year (and years) ahead.

  • What Systems Are Needed To Create A Viable Biosimilar Market?
    What Systems Are Needed To Create A Viable Biosimilar Market?

    In the U.S., interchangeability has often been regarded as a golden ticket to greater uptake. But the EU’s experiences reveal a different story.

More From Biosimilar Regulatory solution center

ABOUT BIOSIMILAR REGULATIONS

The first biosimilar was approved for the European market in 2006. While the regulatory pathway for biosimilars in the U.S. was created as part of the Affordable Care Act in March 2010, the first biosimilar was only recently approved for the U.S. market in March 2015.

Biosimilars are essentially generic versions of large molecule biologics. However, the fact they are not exact copies of the reference product makes establishing regulations for their approval and release to market a more complicated process. The WHO, along with many other parties in the pharmaceutical industry, has argued that regulations governing the development and approval of small molecule generics are not appropriate for more complex biological medicines. As such, the WHO set out to establish regulations articulating the efficacy, safety, and quality standards biosimilars must meet and maintain to make it to market. These regulations specify that a biosimilar must prove its biosimilarity to a reference product through head-to-head comparisons. The biosimilar company must also submit non-clinical and clinical studies data and a pharmacovigilance plan to the appropriate regulatory body. Those navigating the landscape of current biosimilars regulations face the challenge of demonstrating a biosimilar’s safety, purity, efficacy, and potency.

The current U.S. Food and Drug Association (FDA) and European Medicines Agency (EMA) regulations for biosimilars require these biologic copies to undergo extensive analytical chemistry, manufacturing, and control (CMC) and clinical processes to prove similarity to the reference product. However, in comparison to the originator biologic, a biosimilar could see an accelerated approval process, as it might need less data to meet the established regulations. The EMA was the first regulatory authority to establish marketing regulations for biosimilars in 2005. Other countries including Australia, Canada, Japan, Korea, and South Africa have since turned to the EMA’s regulations, as well as the WHO’s regulations, as a model for crafting their own regulations. In 2012, the FDA released three draft guidances to assist biosimilar developers in demonstrating their product’s biosimilarity. To comply with existing U.S. regulations, manufacturers are expected to include structural analysis, functional assays, and data from animal and human clinical trials in their applications. As biosimilar production spreads globally, regulations have continued to shift and evolve. Currently, each governing body has differing definitions/terminology for biosimilars, and as such, has established varying regulations dictating what studies and data are needed to be approved for the market.