• 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?

    Biosimilars were touted as a payer’s tool to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million).

  • 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.

  • How Biosimilar Companies, Employers Can Collaborate, Address Healthcare Challenges
    How Biosimilar Companies, Employers Can Collaborate, Address Healthcare Challenges

    In addition to understanding what influences employers’ health plan decision-making, it’s important to note employers' growing demands for greater pricing transparency and the complexity posed by the lack of an integrated benefits system.

  • The U.K. Biosimilar Commissioning Framework: The Path Toward Implementation
    The U.K. Biosimilar Commissioning Framework: The Path Toward Implementation

    It’s been hard to miss some of the good buzz coming out of the U.K. as the acceptance and adoption of biosimilars continues to be one of the strongest across Europe, and the NHS published its highly anticipated framework to help guide the use of biosimilars. But how the new framework will shape the U.K. biosimilar market is only just being seen.

  • Views From The U.K.: What Biosimilar Evolutions Are Worth Watching?
    Views From The U.K.: What Biosimilar Evolutions Are Worth Watching?

    The first of this three-part article touches on the current biosimilar-related developments ongoing in the U.K., as well as what the new chair of the British Biosimilars Association (BBA) is keeping her eyes on, both in the U.K. and globally.

  • Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”
    Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

    There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

  • 2018 CBI Biosimilars Summit Unveils New Industry Focus Areas
    2018 CBI Biosimilars Summit Unveils New Industry Focus Areas

    As more real-world evidence demonstrating biosimilars’ efficacy and safety is released, I daresay I speak for many in the U.S. who are left asking, “What more do we need?” Well, this event turned me on to a few areas that could use some work and renewed attention.

  • What’s New in U.S. Biosimilar-Land?
    What’s New in U.S. Biosimilar-Land?

    A lot has been promised with the introduction of biosimilars, but can they really deliver a viable alternative treatment to biologics at a substantial savings?

  • How These Hospital Stakeholders Can Benefit Biosimilar Commercialization
    How These Hospital Stakeholders Can Benefit Biosimilar Commercialization

    In Cinfa Biotech’s time preparing for regulatory submission and, hopefully, a future product launch, Jankowsky has noted the increasingly significant role pharmacists play in educating doctors. Much of this comes down to their holistic method of approaching biosimilars — and this was integral in establishing the company’s rationale for development.

  • What Challenges Should Biosimilar Companies Expect In 2018?
    What Challenges Should Biosimilar Companies Expect In 2018?

    Whether they be IP-,real-world-data-, or ongoing market-access-related challenges, biosimilar companies should expect a busy year ahead. Biosimilar Development's editorial advisory board members share the challenges they're keeping their eyes on.

  • 2018 Outlook: Biosimilar Trends To Watch
    2018 Outlook: Biosimilar Trends To Watch

    Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

  • Patent Eligibility Of Biologic & Biosimilar Patents — A Primer
    Patent Eligibility Of Biologic & Biosimilar Patents — A Primer

    If the trend continues, inventions directed to methods of treatment (especially for follow-on indications), or even compositions and formulations, are susceptible to Section 101 challenges, whereas those directed to delivery systems or manufacturing processes appear to be still safely within the “patent eligible” subject matters.

  • Did The 2017 Biosimilar Industry Pave The Way For A Productive 2018?
    Did The 2017 Biosimilar Industry Pave The Way For A Productive 2018?

    In the first installment of this three-part Q&A, I asked the members of the inaugural Biosimilar Development editorial advisory board to share their thoughts on significant 2017 developments and how they expect these will impact the industry in 2018.

  • What Types Of Life Sciences Patents Are Vulnerable To Section 101 Challenges?
    What Types Of Life Sciences Patents Are Vulnerable To Section 101 Challenges?

    To be entitled to a patent, an invention must satisfy a number of patentability requirements, including the “patent eligibility” requirement under 35 U.S.C. § 101.  In Part 1 of this three-part series, we reviewed the origin of the three “patent ineligible” subject matters, the evolution of the U.S. Supreme Court’s jurisprudence on the issue, and how the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Labs, Inc. changed the patent-eligibility landscape for life science patents.

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.