• 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. 

  • 3 Crucial Discussions From The Biosimilar Medicines Conference
    3 Crucial Discussions From The Biosimilar Medicines Conference

    After roughly four years of writing about biosimilars, I can finally say I attended the Annual Biosimilar Medicines Conference. This conference was valuable to get a closer look at Europe as well, not only to see where things are working, but also where they're not.

  • Biosimilars In The Hospital Market, Then And Now: Addressing The Challenges
    Biosimilars In The Hospital Market, Then And Now: Addressing The Challenges

    About 12 years ago, while working at a group purchasing organization (GPO), I had my first conversations with pharma/biotech companies about the possibility of developing and launching biosimilar drugs. Part of my role at the GPO was related to tracking and commenting on policies CMS and the FDA were developing.

  • What’s In A Name? FDA Proposes Updates To Its Biosimilar Naming Policy
    What’s In A Name? FDA Proposes Updates To Its Biosimilar Naming Policy

    The U.S. FDA issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update (“guidance”). This update is the FDA’s second attempt at a policy for nonproprietary name suffixes for biologic products. It also highlights the perceived tension between the FDA’s pharmacovigilance role and its goal of increasing the availability of biosimilars. At least for this round, the FDA’s interest in tracking pharmacovigilance data seems to have received priority.

  • Top 4 Takeaways From The BioTech Pharma Summit
    Top 4 Takeaways From The BioTech Pharma Summit

    Last week, I had the pleasure of chairing the first day of the BioTech Pharma Summit: Biologics and Biosimilars conference in the gorgeous Porto, Portugal. (Don’t ask me how much I spent I spent on port wine in the days before the conference.) The conference was — shockingly — the first European biosimilar conference I have attended in my tenure as a biosimilars editor. (Even though Europe is leaps and bounds — and then more bounds — ahead of the U.S. with biosimilars.)

  • How Can Manufacturers, Oncologists Prepare For The Oncology Biosimilar Boom?
    How Can Manufacturers, Oncologists Prepare For The Oncology Biosimilar Boom?

    A few months ago, I read a fabulous Q&A in Managed Care Magazine featuring oncologist Gary Lyman and co-director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center. In this day and age, we regularly come across surveys or discussions emphasizing how much more work we have to do in the education realm to ensure physicians’ comfort with biosimilars. But after reading Lyman’s interview on one cold, dreary January day, I felt buoyed. That’s not to say there isn’t more work to be done, of course. But it was reassuring to see a prominent member of the oncology community express such comfort and confidence in biosimilars.

  • Biosimilars And The BPCIA: Past, Present, And Future
    Biosimilars And The BPCIA: Past, Present, And Future

    While the biosimilar market in the U.S. has gotten off to a relatively slow start compared to Europe, where biosimilars have been available since 2006, it has recently gained momentum and will continue to grow in the coming years as more “blockbuster” biologics lose regulatory exclusivity and patent protection. Here we review our observations in the biosimilar space since the enactment of the 2009 Biologics Price Competition and Innovation Act (BPCIA) and our view of the future of biosimilars and related patent disputes.

  • Rebates, Integrated Health Models, And Biosimilars: Employers On Lowering Costs Of Care
    Rebates, Integrated Health Models, And Biosimilars: Employers On Lowering Costs Of Care

    Two employer experts lay out the challenges rebates pose, both for employers and biosimilar uptake, as well as the increasing importance of greater integration amongst employers and health systems from both a biosimilar utilization and an overall cost savings standpoint. 

  • Biosimilars Pipeline Shows Remarkable, Sustained Growth
    Biosimilars Pipeline Shows Remarkable, Sustained Growth

    The biosimilars pipeline is progressing rapidly and continues to grow, with more products and more organizations involved. This article reviews the current biosimilars development pipeline and progress. 

  • One Issue Tailor-Made For Biosimilar Maker-Employer Collaboration
    One Issue Tailor-Made For Biosimilar Maker-Employer Collaboration

    In the first of what will be a two-part article, I’ll share two employer organization experts' thoughts on current reimbursement models for biosimilars and how employers and manufacturers can to reshape these practices to bring biosimilars more regularly into employer negotiations.      

  • Recent Reimbursement Policies Aim To Shake Up Biologics Buy-And-Bill
    Recent Reimbursement Policies Aim To Shake Up Biologics Buy-And-Bill

    As policy makers release new policies to reduce healthcare spending, it’s imperative that biosimilar companies emphasize that lowering drug prices and cutting reimbursement are not the same thing. The latter could have serious consequences for critical classes of medicines, including biosimilars.   

  • Two Biosimilar Policies Raise Questions About Reimbursement Consistency
    Two Biosimilar Policies Raise Questions About Reimbursement Consistency

    In the first of this two-part article, I’ll discuss two current policies that could impact biosimilars in the U.S. — in particular, coding evolutions and the pass-through status debate — and some of the yet-unanswered questions they raise about reimbursement consistency between biosimilars and their reference products.   

  • Medicare's International Pricing Index — Biosimilar Stakeholders Weigh In
    Medicare's International Pricing Index — Biosimilar Stakeholders Weigh In

    Can use of the Medicare IPI achieve lower drug costs? The consensus is still out. However, it will almost certainly change the way biosimilar manufacturers will have to think about pricing their agents. And it could raise further questions about the wisdom of a biosimilar pipeline for some drug makers.

  • Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway
    Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway

    Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.

  • What Is Skinny Labeling — And Will It Work For Biosimilars?
    What Is Skinny Labeling — And Will It Work For Biosimilars?

    “Skinny labeling” refers to the practice of follow-on drug manufacturers seeking approval for some but not all the indications for which the branded drug has been approved. In the small molecule drug world, it has been a successful strategy for generic drug makers to get around the brand’s follow-on “new use” patents that keep the brand from falling off the “patent cliff” long after the expiration of the original patents. This strategy is starting to be used in the biosimilar realm.

  • 2019 CBI Biosimilars Summit: Sustainability Requires A Step-Wise Approach
    2019 CBI Biosimilars Summit: Sustainability Requires A Step-Wise Approach

    Just as the FDA emphasized that companies should take a “step-wise” approach to biosimilar development, I’d argue this same approach needs to be embraced in our commercialization and education efforts moving forward.

  • The Evolving Landscape Of Medical Science Liaisons
    The Evolving Landscape Of Medical Science Liaisons

    Though the report does not focus specifically on the role of MSLs in the biosimilar space, there were a few salient points to note for biosimilar companies as they consider the evolving roles and integration of these teams.

  • How Would Proposed Congressional Price Control Policies Impact Biosimilars?
    How Would Proposed Congressional Price Control Policies Impact Biosimilars?

     

    Sen. Bernie Sanders has introduced three bills aimed at reducing prescription drug prices, two of potential importance to biosimilar developers. This article discusses these cost-containment policies, as well as two other congressional initiatives to watch.

  • Why This Biosimilar Initiative Is One To Watch In 2019
    Why This Biosimilar Initiative Is One To Watch In 2019

    When news came my way in early December that the Biosimilars Forum had established the Biosimilars Roundtable, which would be a working group comprising members of 40 different stakeholder organizations, I was thrilled.

  • What RWE Questions, Trends Must Biosimilars Embrace In 2019?
    What RWE Questions, Trends Must Biosimilars Embrace In 2019?

    In this article, I share the (very) few examples of real-world evidence I found in 2018 that served as outliers compared to all the positive biosimilar data. I’ll also explore the ways RWE being released today is evolving beyond the single switching studies we’ve grown accustomed to in the past two years.

  • Biosimilar “Fake Views” Roundup
    Biosimilar “Fake Views” Roundup

    The end goal of this creative biosimilar-related work of fiction is to reflect upon and make light of the most prominent market hurdles we’ve faced thus far in the biosimilar industry.

  • Biosimilar Experts Pinpoint 2019’s Biggest Industry Challenges
    Biosimilar Experts Pinpoint 2019’s Biggest Industry Challenges

    As we enter 2019, editorial board experts share their thoughts on what challenges will be top-of-mind for biosimilar companies, trade groups, and payers, as we progress into the new year.

  • Top 5 Biosimilar Developments Of 2018
    Top 5 Biosimilar Developments Of 2018

    As the industry matures, I’m finding it harder and harder to single out one specific news headline as being the most influential. Rather, each of these Top 5 encompasses a series of events that, together, have further defined and carried this industry forward.

  • Why 2018 Was The Year Of Real-World Evidence
    Why 2018 Was The Year Of Real-World Evidence

    In the first of what will be two articles on this topic, I unpack some of the most impactful real-world evidence releases or efforts implemented over the past year, as well as which of the biggest biosimilar questions were answered over the past year.

  • How This Employer-Driven Initiative Could Revolutionize Biosimilar Use
    How This Employer-Driven Initiative Could Revolutionize Biosimilar Use

    Using what The Coalition’s President and CEO Troy Ross has termed “3D thinking” through the creation of data mapping, employers are gaining access to information they’ve never been privy to before that will enable them to identify savings opportunities and better design their benefits — which could mean increased traction for biosimilars.

  • How Will Medicare’s International Pricing Index Model Affect Biosimilars?
    How Will Medicare’s International Pricing Index Model Affect Biosimilars?

    CMS has announced a new payment model that seeks to reduce out-of-pocket costs for patients. This payment model arises out of the Trump administration’s American Patients First Blueprint that was released earlier this spring. CMS is providing this notice of its proposed payment model via an Advance Notice of Proposed Rulemaking (ANPRM), meaning a formal proposed rule will be introduced in the near future. Comments close on this ANPRM on Dec. 31, 2018.

  • What Biosimilar Metamorphoses Are In Store For 2019?
    What Biosimilar Metamorphoses Are In Store For 2019?

    In the second of this three-part "Ask the Board" series, Biosimilar Development's editorial board members discuss their predictions on how biosimilar development, market access, commercialization efforts, and regulatory and reimbursement policies will evolve in 2019.

  • How Can The U.S. FDA, CMS, And HHS Help Biosimilars In 2019?
    How Can The U.S. FDA, CMS, And HHS Help Biosimilars In 2019?

    In the second part of this two-part article, I unpack how the FDA could solve one particularly challenging market barrier and why we should expect to see (and call for) more from other government agencies in 2019.

  • 2018 Biosimilar Triumphs And Tribulations: How Have Market Expectations Evolved?
    2018 Biosimilar Triumphs And Tribulations: How Have Market Expectations Evolved?

    In the first part of a three-part “Ask The Board” series, members of the editorial board share what left them feeling the most heartened or concerned in 2018 and what must take center stage as we head into 2019.

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.