• 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.

  • Biosimilar Makers To Congress: Time To Act On REMS Legislation
    Biosimilar Makers To Congress: Time To Act On REMS Legislation

    REMS and voluntary restricted distribution programs have become a significant stumbling block for biosimilar companies. The Subcommittee on Health Care, Benefits, and Administrative Rules recently held a hearing on these controversial practices. If there was one big takeaway from the presenting witnesses, it’s that the biosimilars industry is ready for legislative action against these abuses.

  • Opinion On FDA’s Biosimilar Review Pace “Depends On Where You Sit”
    Opinion On FDA’s Biosimilar Review Pace “Depends On Where You Sit”

    In a recent policy briefing, Congress emphasized its wish to see more biosimilar approvals and market launches over the next five years of BsUFA II. But a panel of experts at this same briefing also brought a variety of different experiences and relationships with biosimilars, and, as such, different perceptions on the pace at which the biosimilar market is developing. 

  • Congress Calls For More Efficient BPCIA, Biosimilar Approvals
    Congress Calls For More Efficient BPCIA, Biosimilar Approvals

    The Atlantic and The Biosimilars Council recently teamed up to hold a policy briefing, interviewing the chairman of the House Energy and Commerce Committee, Representative Michael Burgess. This provided a valuable opportunity to hear Burgess, who is at the center of the recent ACA and user fee negotiations, speak on the upcoming BsUFA reauthorization and the role of Congress in furthering the BPCIA.

  • 6 Predictions About Biosimilars In A Hospital Setting
    6 Predictions About Biosimilars In A Hospital Setting

    AmerisourceBergen's Dave Picard, VP of biosimilars and injectables, offers valuable insight into current market dynamics and how biosimilars will fit into current hospital distribution models.

  • Biosimilar Takeaways From Recent Energy And Commerce Hearing
    Biosimilar Takeaways From Recent Energy And Commerce Hearing

    I recently watched the livestream of the Energy and Commerce Committee’s hearing on the FDA’s Generic Drug (GDUFA) and Biosimilar User Fee (BsUFA) programs. >While the overarching argument was that Congress should reauthorize these user fee programs, I came away with a few more takeaways worth noting for the biosimilar community.

     

  • New Medicare Proposals Could Impact Biosimilar Competition
    New Medicare Proposals Could Impact Biosimilar Competition

    In early January, both Pew and MedPAC presented several suggested changes to current Medicare Part B policy. Though these two organizations' proposals have their differences, the ultimate goal of both is to encourage competition between biosimilars and reference products, which would help with affordability for biologics.

  • The 4 Most Notable Biosimilar Interchangeability Hurdles
    The 4 Most Notable Biosimilar Interchangeability Hurdles

    Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the bar it sets for attaining interchangeability.

  • IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment
    IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment

    I recently attended the IQPC Biosimilars Analytical Similarity, Clinical Studies, and Market Entry conference. This event, which took attendees into the heart of biosimilar development (the analytical and statistical work) was a great example of the scientific challenges developers may face while working with different regulatory agencies.

  • Should Your Biosimilar Really Be A Biobetter?
    Should Your Biosimilar Really Be A Biobetter?

    A few months ago, Eagle Pharmaceuticals agreed to acquire Arsia Therapeutics.This move will help Eagle partner with biosimilar companies to turn biosimilar candidates into biobetters. As Eagle CEO Scott Tarriff describes, the company’s business model of reformulating and improving existing small molecules is well-suited to the biologics space — especially considering his expectations of how the biosimilar space will play out.

  • 2017: A Standstill Year For Biosimilars?
    2017: A Standstill Year For Biosimilars?

    Despite the many positive steps we’ve taken to establish the biosimilar industry today, it seems as though the success of the biosimilar market in the U.S. is still looking hazy. Every conference I’ve gone to has focused on the challenges facing the industry and concerns over the different regulations being established. But CBI’s 12th Biosimilars Summit felt particularly realistic in how it approached those issues.

  • Celltrion: Data Transparency Imperative For Biosimilar Success
    Celltrion: Data Transparency Imperative For Biosimilar Success

    Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”

  • FDA Biosimilar Naming Guidance Reveals Larger Healthcare Needs
    FDA Biosimilar Naming Guidance Reveals Larger Healthcare Needs

    Though there weren't any major surprises within the FDA's newly released final biosimilar naming guidance, the agency's decisions raise some even bigger questions about the identification of biosimilars in the future.

  • Top 5 Biosimilar Developments Of 2016
    Top 5 Biosimilar Developments Of 2016

    In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.

  • Health Canada’s Unique Approach To Biosimilar Regulation
    Health Canada’s Unique Approach To Biosimilar Regulation

    Health Canada recently released its revised guidance document on biosimilar submission requirements. Though the revisions were primarily “clarifications,” not major policy changes, some of these amendments provide a glimpse into the more unique aspects of Canada’s relationship with biosimilars.

  • The Case For Moving The EMA To Ireland
    The Case For Moving The EMA To Ireland

    Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.

  • Congress Takes On Biosimilars
    Congress Takes On Biosimilars

    During an interview at a briefing held by The Atlantic and The Biosimilars Council, Senator Bill Cassidy of Louisiana presented some valuable insights into where he believes more work needs to be done to ensure biosimilars’ market success.

  • FDA Stresses Scientific Alignment, Not Harmonization For Global Biosimilars
    FDA Stresses Scientific Alignment, Not Harmonization For Global Biosimilars

    In most cases, the biosimilar guidelines put forth by all the major regulatory agencies are quite similar. But there are some differences that can challenge companies looking to have their biosimilars approved in these different countries. 

  • The Many Gray Areas Of Biosimilar Commercialization
    The Many Gray Areas Of Biosimilar Commercialization

    Commercialization is one of the hottest topics of discussion in the biosimilar industry, perhaps because, so far, the path to commercial success is far from black and white.

  • Changes In Regulatory Requirements For Biosimilar Development In India
    Changes In Regulatory Requirements For Biosimilar Development In India

    In August 2016, India’s Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology revised the September 2012 Guideline for Similar Biologics. The revision was done to keep pace with ever changing global standards and to streamline the regulatory process for the authorization of biosimilars in India. What do biosimilar makers need to know?

  • How To Approach U.S. Physicians About Biosimilars
    How To Approach U.S. Physicians About Biosimilars

    As the U.S. faces its first biosimilars for oncology, rheumatology, dermatology, and gastroenterology indications, a new publication from the Biosimilars Forum shows there’s quite a bit of work to be done to educate U.S. physicians.

  • How To Make The Most Of Your FDA Biosimilar Meetings
    How To Make The Most Of Your FDA Biosimilar Meetings

    The FDA's John Jenkins shares several reasons why biosimilar makers shouldn't let their eagerness to get to market drive their development program.

  • How These Biosimilar Unknowns Could Impact Manufacturers
    How These Biosimilar Unknowns Could Impact Manufacturers

    During my time covering biosimilars, I’ve grown well-versed in some of these arguments, including those around naming, labeling, and reimbursement. But several discussions in the past few months have added new layers of complexity to these issues.

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.