• 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.

  • How Can The FDA Take Ownership Of Biosimilars In 2019?
    How Can The FDA Take Ownership Of Biosimilars In 2019?

    In lieu of the slow development of the U.S. biosimilar market, the FDA has stepped up to determine how it can improve biosimilar education, regulation, and market access. As many of the industry comments to the Biosimilar Action Plan revealed, this will require the FDA to continue broadening its purview and refining the regulatory pathway by implementing several specific actions.

  • The Biosimilar Market Is Evolving: How Can Education Strategies Follow Suit?
    The Biosimilar Market Is Evolving: How Can Education Strategies Follow Suit?

    In this article, I’ll discuss the importance of one commonly overlooked expert and highlight one recent educational initiative that exemplifies current needs in biosimilar communication strategies.  

  • Express Scripts New Flex Formulary: Biosimilar Friend Or Foe?
    Express Scripts New Flex Formulary: Biosimilar Friend Or Foe?

    Though it’s much too early to say for sure, we will need to watch how this formulary impacts the brand vs. biosimilar landscape, and, in turn, the performance of biosimilars in the pharmacy reimbursement space.

  • How Will Trump’s New FTC/DOJ Reporting Requirements Impact Biosimilars?
    How Will Trump’s New FTC/DOJ Reporting Requirements Impact Biosimilars?

    On Oct. 10, 2018, President Trump signed into law the Patient Right to Know Drug Prices Act, which, among other things, requires that certain biosimilar applicants and reference product sponsors involved in patent disputes file their settlement agreements with the FTC and the DOJ. This article summarizes the key provisions of the new law and discusses its limitations.

  • If Four-Letter Suffixes Aren’t Used In Biosimilar Tracking, What Use Are They?
    If Four-Letter Suffixes Aren’t Used In Biosimilar Tracking, What Use Are They?

    The implementation of the Biologics Price Competition and Innovation Act1 (BPCIA) raised a number of critical issues for manufacturers, payers, and prescribers. These include the big-picture questions of extrapolation of indications, interchangeability, and a radical new approach to evaluating the comparability of these drugs to their reference biologics, as well as approving them.

  • A Biosimilar Manufacturer’s Sword & Shield Against Doctrine Of Equivalents Claims
    A Biosimilar Manufacturer’s Sword & Shield Against Doctrine Of Equivalents Claims

    While biosimilar manufacturers face many unique challenges in patent litigation, one of the most common is an infringement action brought under the doctrine of equivalents (DOE). DOE is a principle where a party sues for infringing on the general spirit of the patent, rather than on the specific content of its claims.

  • Biosimilar Policies To Watch As We Approach 2019
    Biosimilar Policies To Watch As We Approach 2019

    I reached out to Biosimilar Development editorial board member Molly Burich of Boehringer Ingelheim for her input on the policies she expects could have the largest positive or negative impact on biosimilars, as well as what progress has been made on the policy front.

  • The Current State Of U.S. Biosimilar Policies — An Overview
    The Current State Of U.S. Biosimilar Policies — An Overview

    With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilars may offer is intriguing to many policymakers as well as those in the industry. 

  • A Possible “Humirageddon:” Perspectives On The EU Biosimilar Launch
    A Possible “Humirageddon:” Perspectives On The EU Biosimilar Launch

    In the wake of the arrival of Humira biosimilars in the EU, Jorge Santos da Silva and Jennifer Heller of McKinsey & Company share several critical pricing and market considerations for companies as this highly anticipated product finally becomes available to patients.

  • Internal And External Risks To Biosimilar Companies And The Path Forward
    Internal And External Risks To Biosimilar Companies And The Path Forward

    There are many challenges to walk through to truly understand the opportunity, the risks, and the best path forward for biosimilars, but the best thing would be to start by recognizing the external and internal risks that likely every player in the space is facing.

  • Biosimilar Regulatory Inefficiencies: Would Data Sharing Violate The U.S. Constitution?
    Biosimilar Regulatory Inefficiencies: Would Data Sharing Violate The U.S. Constitution?

    One of the regulatory inefficiencies the FDA is trying to address is the current requirement for bridging studies to submit data comparing a biosimilar to a non-U.S. licensed product.

  • The Humira Biosimilar Tsunami Cometh: What Can We Expect?
    The Humira Biosimilar Tsunami Cometh: What Can We Expect?

    In the first segment of this two-part Q&A article, da Silva and Heller share their perspectives on the EU market potential for Humira biosimilars, which markets they expect will be most dynamic from a competition standpoint, and what Humira biosimilar players can learn from previous tumor necrosis factor (TNF) biosimilar launches.

  • What To Watch For In The Implementation Of FDA’s Biosimilar Action Plan
    What To Watch For In The Implementation Of FDA’s Biosimilar Action Plan

    In July 2018, the FDA unveiled a Biosimilar Action Plan (BAP) intended to “facilitate the efficient development and approval” of biosimilars. This article discusses two significant elements of the BAP.

  • Biosimilar Education: The Elements Of An Effective Strategy
    Biosimilar Education: The Elements Of An Effective Strategy

    In this first of what I expect will be several articles, I will lay out one of the current educational gaps I’ve noticed, as well as introduce real educational examples or efforts I’ve encountered (or would like to see more of) that show promising and widely adaptable pathways forward.

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.