• 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.

  • Off The Beaten Path: 3 Strategies For Improving World-Wide Biosimilar Access
    Off The Beaten Path: 3 Strategies For Improving World-Wide Biosimilar Access

    Low- and middle-income nations naturally demand different approaches, and, there is, of course, still much work to be done to bolster biologics use in these countries. This article continues that discussion, illuminating several specific strategies companies can explore to better reach a wide variety of countries and patients.

  • Charting A Biosimilar Course In Low- And Middle-Income Nations
    Charting A Biosimilar Course In Low- And Middle-Income Nations

    Though entering some of these nations will not be for the faint of heart, Iyer believes the solution to these access issues is closer than we realize.

  • Could Naive Patients Be The Key To U.S. Biosimilar Success?
    Could Naive Patients Be The Key To U.S. Biosimilar Success?

    A decade after the primary negotiations that resulted in the BPCIA, it is safe to say the promise of biosimilars is yet to be realized. As it turns out, perhaps naivety, in a clinical sense, is the solution.

  • How Can We Make FDA’s Biosimilar Action Plan A Game-Changer?
    How Can We Make FDA’s Biosimilar Action Plan A Game-Changer?

    Despite all the FDA’s efforts to increase review time and get products to market more quickly, I remain unconvinced that the BAP will turn around the U.S. market — at least not our current market. So what can we do in the meantime?

  • 4 Revelations From The FDA’s Biosimilar Part 15 Hearing
    4 Revelations From The FDA’s Biosimilar Part 15 Hearing

    In addition to laying out some of the concerning themes that came up throughout the hearing, I will unpack some of the FDA’s lines of inquiry which I feel illuminated the agency’s efforts to challenge certain claims for the first time. 

  • Biosimilar Access: Is The Industry Overlooking Critical Markets?
    Biosimilar Access: Is The Industry Overlooking Critical Markets?

    Though there’s much to write about the successes and pitfalls in the European, U.S., and Canadian biosimilar markets, it turns out there’s quite a bit that biosimilar makers need to learn about the countries off the beaten market-access path. And in many of these nations, the capacity for a biologics market already exists.

  • What Brazil Can Learn From Denmark’s Biosimilar Policies
    What Brazil Can Learn From Denmark’s Biosimilar Policies

    In this article I continue to outline some of the Brazil Ministry of Health's biggest questions about post-market surveillance, big data, and procurement, as these are particularly telling of how the nation’s biosimilar policy could take shape in the future.

  • How The Regulatory Pathway Shapes Biosimilar Business Decisions
    How The Regulatory Pathway Shapes Biosimilar Business Decisions

    I took the opportunity to pick editorial board member Hubert Chen's brain about the ins and outs of the 505(b)(2) pathway, which led to an even larger discussion about the critical impact a regulatory pathway can have on a company's business decisions and strategies.

  • Brazil’s Ministry Of Health Weighs Biosimilar Safety, Interchangeability
    Brazil’s Ministry Of Health Weighs Biosimilar Safety, Interchangeability

    Though the extent to which biosimilars will be used in Brazil is still unclear, I’m hopeful that several discussions on safety, efficacy, and interchangeability will provide a successful path forward for the country.

  • What Can Biosimilar Developers Learn From The 1990s Biopharma Industry?
    What Can Biosimilar Developers Learn From The 1990s Biopharma Industry?

    This article highlights some of the early biologics industry decisions and thought processes and the subsequent actions and opportunities biosimilars create for the pharma industry.

  • Biosimilars In Brazil: Healthcare Salvation Or Waterloo?
    Biosimilars In Brazil: Healthcare Salvation Or Waterloo?

    I was recently given a first-hand look at some of the unique market-related challenges standing in the way of Brazil taking full advantage of biosimilars. In the first of this two-part article, I will provide a closer look at some of these challenges and what these may mean for the Brazilian biosimilar industry moving forward.  

  • The Doctrine Of Equivalents — A Major Barrier For The Marketability Of Biosimilars
    The Doctrine Of Equivalents — A Major Barrier For The Marketability Of Biosimilars

    Often there is a great deal of confusion regarding why manufacturers wait so long to market their biosimilars despite having a more abbreviated pathway than innovator biologics. Other times, manufacturers and investors will be caught off-guard when a court blocks marketing of their biosimilars despite them having obtained FDA approval. Mitigating preventable uncertainty warrants understanding some of the underlying mechanisms related to the “patent dance.” This is the first of two articles that will address the patent infringement issues often used against biosimilars by sponsor biologic owners to delay or derail marketing of the biosimilar.     

  • A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief
    A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief

    This article explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.

  • The Great Canadian Biosimilar Transition: One Payer’s Strategy
    The Great Canadian Biosimilar Transition: One Payer’s Strategy

    Green Shield Canada, a private payer, has created a biosimilar policy and is currently rolling out a pilot biosimilar transition program among its clients. Though it’s still in the early stages, this is an intriguing program to keep our eyes on as the market advances in Canada.

  • The Search For Biosimilar Value: The Devil Is In The Details
    The Search For Biosimilar Value: The Devil Is In The Details

    In many situations, value is associated with the price tag, and, specifically, the savings associated with a certain product. But there are still questions of how biosimilar value can be presented to stakeholders, especially since it can feel as though there is a missing part in the equation.

     

  • Patentable Subject Matter Barriers For Biosimilars — And How To Overcome Them
    Patentable Subject Matter Barriers For Biosimilars — And How To Overcome Them

    Patents are the most important requirement for successful biologic commercialization, yet stakeholders often have little understanding of the unique obstacles encountered in this field, especially for biosimilars. Biologics may treat less than 2 percent of the U.S. population, but they account for 38 percent  of all U.S. prescribed drug spending.

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.