• 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.

  • What To Watch In The Biosimilar Regulatory Space
    What To Watch In The Biosimilar Regulatory Space

    Though none of the regulatory issues discussed will be resolved right away, you can guarantee these will become regular parts of the dialogue between the industry and regulators in the years ahead.

  • EU Turns Focus To Biosimilar Sustainability Questions
    EU Turns Focus To Biosimilar Sustainability Questions

    As Julie Maréchal-Jamil of Medicines for Europe shared, the biggest questions in Europe now circle around sustainability — particularly whether market policies, procurement mechanisms, and benefit sharing models are in sync with the system's needs, and if they can teach nations that have yet to seize the biosimilar opportunity.

  • Can Real-World Evidence Improve Market Access For Biosimilars In The U.S.?
    Can Real-World Evidence Improve Market Access For Biosimilars In The U.S.?

    A look at the role real-world evidence (RWE) can play in increasing the uptake of biosimilars in the U.S. market and some of the challenges in leveraging the potential of RWE.

  • Why The Biosimilar Industry Should Celebrate The Latest FDA News
    Why The Biosimilar Industry Should Celebrate The Latest FDA News

    A number of articles already provide a synopsis of the FDA's reversal on the Statistical Approaches draft guidance. But I felt it was necessary to add one more article to this conversation, not only because this action is unprecedented thus far in the biosimilar industry, but it also suggests an important turning point in the FDA’s biosimilar oversight.

  • “Locally Brilliant": 3 Biosimilar Market Access Experiences
    “Locally Brilliant": 3 Biosimilar Market Access Experiences

    Mundipharma expert Richard Trollope shares his learnings from launching three different biosimilar molecules (Remsima, Truxima, and Herzuma) in the EU and discusses the questions that remain about the newly launched Herzuma, recently introduced in the U.K. and Germany.

  • Pfizer Collaborates to Accelerate Approval of Biosimilar MAbs in China
    Pfizer Collaborates to Accelerate Approval of Biosimilar MAbs in China

    As Pfizer began its pursuit of delivering two biosimilar monoclonal antibodies (mAbs) in China, it sought a partner that could mitigate the risks of expanding into this region while also significantly reducing the development timeline. By leveraging the expertise of an experienced partner and the benefits of single-use technology (SUT), Pfizer was able to quickly establish a global footprint while also gaining a competitive advantage in an emerging market.

  • How Recent Regulatory & Payer Developments Impact U.S. Biosimilar Access
    How Recent Regulatory & Payer Developments Impact U.S. Biosimilar Access

    In this second installment of a three-part series, industry stakeholders discuss recent developments in the U.S. marketplace from both the regulatory and payer viewpoints, with an emphasis on how these may lead to opportunities for biosimilar manufacturers.

  • Critique Of Literature Review Highlights Areas For Future Study And Education
    Critique Of Literature Review Highlights Areas For Future Study And Education

    A recently published literature review of biosimilar switching studies drew some pushback in the form of a letter to the editor. Though this letter may seem, on the surface, another frustrating bump in the road, it raises several new, important lines of inquiry for biosimilar makers and stakeholders to explore in future publications.

  • Market Access Impediments: Where Should Biosimilars Go From Here?
    Market Access Impediments: Where Should Biosimilars Go From Here?

    In this first article of a three-part roundtable industry experts share their insights on the status of the market for biosimilars and explore some of the reasons for the difference between the U.S. and Europe.

  • Recent Conference Reveals Growing Wave Of Biosimilar Social Responsibility
    Recent Conference Reveals Growing Wave Of Biosimilar Social Responsibility

    I’ve heard it said that innovation in the biosimilar world extends beyond the actual scientific and technical development of the product; innovation also applies to the act of changing and shaping regulations and perspectives. This year’s conference really emphasized the specific tasks being carried out by members of biosimilar companies, patient advocacy groups, payers, and research organizations to change and advance perspectives.

  • Recent Supreme Court Decisions On Inter Partes Review — What Biosimilar Developers Need To Know
    Recent Supreme Court Decisions On Inter Partes Review — What Biosimilar Developers Need To Know

    The U.S. Supreme Court recently issued two decisions related to inter partes review (IPR). This article will briefly introduce IPR, discuss the Supreme Court’s decisions, explain how these decisions may impact IPR and biosimilar companies, and suggest how biosimilar companies should respond.

  • Amgen And Avalere Reports Reveal "Upside Down" Payer Biosimilar Realities
    Amgen And Avalere Reports Reveal "Upside Down" Payer Biosimilar Realities

    While Amgen’s report shares payers’ broad considerations about biosimilars and the impact they’d have, Avalere’s report digs more deeply into the available data from payers to show just how biosimilars are stacking up. And, frankly speaking, I found some of the information quite concerning.

  • 6 Ways Biosimilar Companies Should Engage State Governments
    6 Ways Biosimilar Companies Should Engage State Governments

    This article provides insights and several solutions for biosimilar companies to engage local politicians and patients in a manner that is mutually beneficial. 

  • Why Medicare Pass-Through Status Must Remain For Biosimilars
    Why Medicare Pass-Through Status Must Remain For Biosimilars

    A U.S. House-passed version of the Continuing Resolution (CR) threatened to remove an integral tool for biosimilar reimbursement under Medicare Part B. Though this tool (pass-through status) will remain for biosimilars, this ultimately raises questions about the importance of pass-through status and how eliminating it could impact the industry as a whole.

  • Why Biosimilar Makers Should Pay More Attention To U.S. State Governments
    Why Biosimilar Makers Should Pay More Attention To U.S. State Governments

    A critical mechanism in the U.S. constitutional framework is often overlooked in a larger public affairs strategy — the right of a state to govern itself in most aspects. This article conveys the importance of shifting resources from the federal campaign efforts to a more local effort to ensure biosimilar success.

  • Economics And The Clinic: What Biosimilar Manufacturers Must Consider
    Economics And The Clinic: What Biosimilar Manufacturers Must Consider

    In the second of this two-part article, McKesson Specialty Health's Omar Hafez and Pete Perron discuss how to approach the complex financial landscape in the clinic and help incentivize clinics to use biosimilars.

  • How Should Biosimilar Companies Approach Real-World Evidence?
    How Should Biosimilar Companies Approach Real-World Evidence?

    Real-world evidence (RWE) has become increasingly important for innovative manufacturers looking to convince reluctant payers that their new medicine has a place in patient care. Indeed, many claim the changing nature of the data landscape in healthcare will revolutionize the way we consider evidence, but does this apply to biosimilars? Is there a real need to look at data from actual clinical practice before or after market entry for these products?

  • The Importance Of Humanizing Biosimilars
    The Importance Of Humanizing Biosimilars

    Since I will be unable to attend the upcoming Biosimilar Medicines Conference this year, I welcomed the opportunity to speak with Mylan's and the Biosimilar Medicines Group's Erin Federman about which topics she hopes to see discussed and how certain conversations surrounding biosimilars could be reframed.

  • Pfizer Executives Elaborate On Payer Biosimilar Contracting Goals, Challenges
    Pfizer Executives Elaborate On Payer Biosimilar Contracting Goals, Challenges

    At a recent press conference, Pfizer executives shared a few key updates related to Inflectra’s uptake and the ongoing efforts to work with commercial payers. These updates not only shed more light on Inflectra’s market journey, but also reassured me that progress is being made — even though it’s not regularly broadcast in headlines.

  • Stakeholders To Gather In London To Plan Biosimilar Market’s Future
    Stakeholders To Gather In London To Plan Biosimilar Market’s Future

    This year, The Biosimilar Medicines Group, a Medicines for Europe sector group, will host its 16th annual conference. While I will be unable to attend the event once again this year, I was thrilled to have the opportunity to chat with Carol Lynch, chair of the Biosimilar Medicines Group for Medicines for Europe, about the upcoming conference.

  • The European Biosimilars Landscape: What To Expect In The Year Ahead
    The European Biosimilars Landscape: What To Expect In The Year Ahead

    Europe is set to have another significant year of biosimilar approvals and launches in 2018, following the slew of biosimilar approvals in 2017. Overall, there are now over 40 EC-approved biosimilar products, across 15 different biologic classes.

  • Partnering With Insurers To Improve Biosimilar Access In The U.S.
    Partnering With Insurers To Improve Biosimilar Access In The U.S.

    Drug developers have found a powerful ally in their campaign to advance biosimilar adoption in the U.S. — the nation’s health insurance providers. Insurers are keen to drive down the price of reference biologics, and they view biosimilars as an important way to accomplish that goal.

  • 90 Studies Prove Biosimilars’ Safety And Efficacy: What Now?
    90 Studies Prove Biosimilars’ Safety And Efficacy: What Now?

    This review sought to answer two questions which have been plaguing the biosimilar industry since day one: will biosimilar switching have any impact on safety, and will biosimilars be the harbingers of increased immunogenicity? And it has provided us with far more than just answers to these questions.

  • Could This Practice Increase Biosimilar Use In The U.S.?
    Could This Practice Increase Biosimilar Use In The U.S.?

    What could a country like the U.S. and big payers like the Aetna’s, UnitedHealthcare’s, or even the PBMs like CVS learn from what other countries have done to garner savings for their healthcare systems and potentially reduce costs for patients?

  • How The EU Influences U.S. On Biosimilar Interchangeability & Other Policies
    How The EU Influences U.S. On Biosimilar Interchangeability & Other Policies

    This articles highlights the meaning of the NOR-SWITCH trial results and how the EU’s view of biosimilars as therapeutic alternatives, rather than generics, has influenced U.S. policy.

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.