• Is It Time To Throw In The Towel On Biosimilars In The U.S.?
    Is It Time To Throw In The Towel On Biosimilars In The U.S.?

    Rob Wright takes issue with Peter Bach, M.D., and Mark Trusheim’s recommendation that the U.S. would be better served by abandoning continued biosimilar drug development.

  • A Bite-Sized Analysis Of The PDPRA For Biosimilar Makers
    A Bite-Sized Analysis Of The PDPRA For Biosimilar Makers

    In light of all the noise surrounding this Act, I reached out to reimbursement policy guru and Biosimilar Development editorial board member extraordinaire, Molly Burich. Here, she shares her initial thoughts on how several proposed changes to alter reimbursement under Medicare Part B and D could play out in the biosimilar space should the bill be made law.  

  • 2 Bills, 1 Goal: Lower Drug Prices Through Biosimilars
    2 Bills, 1 Goal: Lower Drug Prices Through Biosimilars

    Just prior to an election season, it is not surprising to see a few bills emerge as potential silver bullets to solve pressing policy issues. One issue that has consumed the public for several years is drug prices. This article examines two Congressional bills aimed at increasing biosimilar utilization in an effort to lower drug costs.

  • A Second Reformation: Returning Biosimilar Regulations To Scientific Roots
    A Second Reformation: Returning Biosimilar Regulations To Scientific Roots

    In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

  • Breast Cancer Patient Organization Sets Sights On Biosimilars
    Breast Cancer Patient Organization Sets Sights On Biosimilars

    During our discussion, I learned more about this patient organization and its biosimilar education goals, as well as what type of information could be particularly helpful for the breast cancer patient community at this point in time.

  • What Can Cell & Gene Efforts Teach Biosimilar Makers?
    What Can Cell & Gene Efforts Teach Biosimilar Makers?

    Not only are the issues impacting cell and gene therapies relatable on the biosimilar side, I’m hoping this particular strategy can inspire creative thinking as scrutiny into the buy-and-bill landscape continues to intensify.

  • Cutting Through The Noise: The Bright Side Of Biosimilar Progress
    Cutting Through The Noise: The Bright Side Of Biosimilar Progress

    Because negative news and opinions seem to create greater waves, I thought I would take stock of the positive news that may not have come over your desks or (more realistically) cellphones in the past few weeks. While it’s easy to get bogged down by negative speculation, there’s progress being made and companies and experts fighting daily to keep this industry moving forward, even if it feels glacial.

  • FDA, USP Debate Standards: How Could This Impact Biosimilars?
    FDA, USP Debate Standards: How Could This Impact Biosimilars?

    Even though the FDA has argued quite passionately against the need for biologics standards, there are several reasons why I hesitate to embrace their arguments that having these standards in place (and requiring they be met) could be harmful to biosimilars.

  • Employer Roundtable Highlights Biosimilar Knowledge Gap
    Employer Roundtable Highlights Biosimilar Knowledge Gap

    Though this event encompassed a small cross-section of employers, the discussions and questions asked about biosimilars revealed the topics that need to be considered, reiterated, and regularly reinforced.

  • The Debate On Standards In Biologics Development Heats Up
    The Debate On Standards In Biologics Development Heats Up

    Though it’s only natural to expect animated scientific discussion between the FDA and USP which have long been partners-in-science, I found myself caught off-guard by just how firmly the FDA has been putting its foot down and making its thoughts known on the role certain standards — in particular, USP monographs — should (or should not play) in biologics development.

  • The Progress And Pitfalls Of Global Biosimilar Development
    The Progress And Pitfalls Of Global Biosimilar Development

    While we’ve certainly seen progress on the march towards true global development, there’s still a way to go. There were several points I learned recently that stood out about which regulatory inconsistencies still exist between developed nations, as well as how certain aspects of regulatory science can be improved upon in the future.

  • How Can Biosimilars Make Headway In The U.S. Market?
    How Can Biosimilars Make Headway In The U.S. Market?

    ISPOR, the professional society for health economics and outcomes research (HEOR), recently held its annual conference, which brought together nearly 4,000 researchers, regulators, payers, drug developers, providers, and other stakeholders from across the healthcare continuum. During one panel session, experts in biosimilar regulatory, legal, and reimbursement discussed the crucial elements needed to foster a robust and sustainable U.S. biosimilars marketplace over the long term.

  • USP Highlights Biosimilar Analytical Development Challenges, Possibilities
    USP Highlights Biosimilar Analytical Development Challenges, Possibilities

    During our conversation about the FDA’s most recent comparability guidance, I picked one USP expert's brain about the challenges of establishing a biosimilar analytical development program, as well as why certain types of data may be more difficult to come by than others. These challenges are responsible for further complicating the question about which types of data are still necessary, and why.  

  • FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?
    FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?

    In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.

  • Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance
    Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance

    Despite the importance of the process the FDA is outlining in the guidance, I’ve surprisingly heard little chatter — positive or negative — about what the agency is now outlining and what this may mean for biosimilars and the biosimilar regulatory paradigm moving forward. Here are a couple of the biggest takeaways to note.

  • Physicians Speak Out About Biosimilar Value
    Physicians Speak Out About Biosimilar Value

    I particularly enjoyed a conversation amongst a panel of physicians at a recent conference, several of whom elaborated upon the value increased use of biosimilars can bring to the table — both for patients and physicians. And though savings and access are main goals, physicians also see another critical benefit of greater biosimilar use.

  • Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?
    Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?

    The debate on drug pricing is raising questions about why U.S. patients pay some of the highest fees in the world to access prescription medicines. Politicians are putting manufacturers of insulins under particular scrutiny.

  • Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents
    Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents

    In recent years there has been growing, bipartisan support to address the perceived high cost of biologic drugs. Indeed, recent estimates are that biologic drugs account for approximately 40 percent of all U.S. pharmaceutical sales and 70 percent of drug spending growth between 2010 and 2015.

  • How Should We Really Feel About FDA’s Biosimilar Interchangeability Guidance?
    How Should We Really Feel About FDA’s Biosimilar Interchangeability Guidance?

    Reading through the two versions of the guidance, I had a few thoughts about some of these changes, which led me to reflect more broadly on their impact on the biosimilar regulatory and development sphere.

  • 4 Takeaways From The FDA’s Insulin Hearing
    4 Takeaways From The FDA’s Insulin Hearing

    Overall, four talking points arose during the presentations that I felt were worthy of briefly singling out. Many of these points touch on the broader discussions happening in the biosimilar sphere, including tailored development, interchangeability, immunogenicity, device innovation, and overall patient and provider education.

  • The China Biosimilars Market: Rise Of A Potential Powerhouse
    The China Biosimilars Market: Rise Of A Potential Powerhouse

    Since 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the US. How does the rise of the China biosimilars market fit this established picture?

  • Physicians And Biosimilar Uptake: How Do We Move Forward?
    Physicians And Biosimilar Uptake: How Do We Move Forward?

    Here, I’ll discuss some of the current physician knowledge gaps in the different therapeutic areas. Similarly, I’ll delve into the discussions surrounding what educational strategies and guidelines may be needed on the hospital or national level to improve physicians’ and patients’ relationships with biosimilars.

  • 5 Intriguing U.S. Biosimilar Policy Questions
    5 Intriguing U.S. Biosimilar Policy Questions

    Biosimilar Development recently hosted a webinar on U.S. biosimilar policies with Frier Levitt Government Affairs expert, Ron Lanton. Here are several questions that came up during the webinar about the impact proposed or current policies may have in the future.

  • How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA
    How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA

    On March 5, 2019, Representative Anna Eshoo (D-CA) introduced H.R. 1520, the “Purple Book Continuity Act of 2019.” The bill addresses the availability of information about approved biological products that may support the development of biosimilar products. It has five cosponsors in the House, drawn from both sides of the aisle, and was considered with five other bills by the House Energy and Commerce Committee on April 3, 2019. The Committee advanced the bill, along with five others, as a step toward addressing runaway drug pricing.

  • HHS Safe Harbor Rebate Proposal: Biosimilars' New Hope?
    HHS Safe Harbor Rebate Proposal: Biosimilars' New Hope?

    On Feb. 6, 2019 the Department of Health and Human Services (HHS) officially proposed the rebate rule known as the “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.”

  • 3 Tips To Advance Biosimilar Education For IBD Patients
    3 Tips To Advance Biosimilar Education For IBD Patients

    Whether it be pointing out specific unmet needs in IBD or suggesting meaningful educational materials for patients, one patient advocate delivered great examples of how manufacturers can support patient advocates and provide them with the information they need most today.

  • How Advocacy Groups, Biosimilar Makers Can Improve Biologics Education For Physicians
    How Advocacy Groups, Biosimilar Makers Can Improve Biologics Education For Physicians

    In this first of two articles, an advocate from the Crohn's and Colitis Foundation shares details about the Foundation’s ongoing initiatives in terms of educating physicians, as well as what can be done to better understand and improve physicians’ biologics and biosimilar prescribing practices.    

  • Analysis Of The Trastuzumab Biosimilar Market As Herceptin Exclusivity Nears An End
    Analysis Of The Trastuzumab Biosimilar Market As Herceptin Exclusivity Nears An End

    Within the last few years, the FDA has taken steps to approve more biosimilar products and has committed to providing for a competitive landscape. The three latest biosimilars to be approved by the FDA have all been biosimilars to Herceptin. Further, Pfizer’s Trazimera, the most recently approved trastuzumab biosimilar, has sparked intrigue. As a result, Genentech is bracing for Herceptin biosimilar commercial launches in 2019.

  • How Will USPTO Guidance Revisions Impact Biosimilars?
    How Will USPTO Guidance Revisions Impact Biosimilars?

    Since 2012, patent stakeholders in the U.S. have faced remarkable uncertainty in the evaluation of patent subject matter eligibility under 35 U.S.C. 101, particularly in the application of the Supreme Court’s Alice/Mayo1 test by the United States Patent and Trademark Office (USPTO). 

  • Biosimilars Vs. Interchangeable Biologics: Which Is A Distraction?
    Biosimilars Vs. Interchangeable Biologics: Which Is A Distraction?

    I found myself puzzled, to say the least, by a recent editorial intriguingly entitled “Biosimilars Are A Distraction.” What I ended up reading were several questionable economic and clinical claims I feel are worth dissecting. 

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.