• 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

    The European biosimilars market is the most mature in the world and continues to gather momentum. Since January 2017, the European Commission (EC) has granted marketing authorization for 19 biosimilar therapeutic medicines that reference seven distinct originator biologics, making it a record period in this region for biosimilar approvals. Overall, there are now over 40 EC-approved biosimilar products, across 15 different biologic classes (as of March 31, 2018).

  • 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.

  • Biosimilar Evolutions To Watch For In The New Year
    Biosimilar Evolutions To Watch For In The New Year

    Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.

  • What U.S. Biosimilar “Traditions” Need To Be Broken In 2018?
    What U.S. Biosimilar “Traditions” Need To Be Broken In 2018?

    You may feel “tradition” is not yet a realized concept in the biosimilar industry — and I would agree with you. But this didn’t stop me from asking several experts which areas they felt could stand more attention or redirection in the future. And they left no stone unturned.

  • Why So Slow? Demystifying The Barriers To U.S. Biosimilar Adoption
    Why So Slow? Demystifying The Barriers To U.S. Biosimilar Adoption

    This article will provide a glimpse into the complex and often misunderstood dynamics of U.S. biosimilar reimbursement that contribute to the state of the market today — a topic that is particularly salient in light of recent policy changes by the Centers for Medicare & Medicaid Services (CMS).

  • The Post-Mayo World Of Life Sciences Patents
    The Post-Mayo World Of Life Sciences Patents

    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 this three-part series, we will look at how the U.S. Supreme Court’s jurisprudence on patent eligibility has evolved, examine the impact of its March 2012 decision in Mayo Collaborative Services v. Prometheus Labs, Inc. on life sciences patent litigation in lower courts, and discuss what it means for patent eligibility of biologic and biosimilar patents.  

  • Biosimilars Face New Destiny Under Medicare Part B Revision
    Biosimilars Face New Destiny Under Medicare Part B Revision

    Starting in 2018, CMS will heed calls to change its existing Medicare Part B policy. Though only time will tell the true impact of these changes, biosimilar makers, patients, and physicians stand to benefit in a few key ways.

  • Tips For Success In The Indian Biosimilar Market
    Tips For Success In The Indian Biosimilar Market

    In part 3 of this three-part series, Basak discusses the challenges of raising funds to develop and commercialize biosimilars in India, provides advice to biosimilar companies looking to enter the market, and shares his vision of the future for biosimilars in India.

  • How This Medicare Part D Proposal Gives Biosimilars Chance To Shine
    How This Medicare Part D Proposal Gives Biosimilars Chance To Shine

    Establishing new language requiring a portion of rebates to be passed on to consumers at the point-of-sale could bode well for biosimilar makers, and especially those that provide a competitive price.

  • Will EU Patent System Changes Speed Market Entry For Biosimilars?
    Will EU Patent System Changes Speed Market Entry For Biosimilars?

    In October 2017, the European Commission issued a consultation seeking input from the public regarding whether improvements can be made to the patent system. The policy questions underlying patent extensions and research exemptions could have a far-reaching impact.

  • CMS’ Decision On Coding For Biosimilars: A Deeper Look
    CMS’ Decision On Coding For Biosimilars: A Deeper Look

    The November 2017 decision by CMS to change the coding practice for biosimilars in the United States is likely to have far-reaching consequences for these drugs, but will all downstream effects be positive?

  • The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers
    The Complex Litigation Surrounding Remicade And Its Biosimilar Challengers

    Control of the Remicade and biosimilar market is being aggressively contested by Janssen, J&J, Celltrion, Hospira, and Pfizer. This article discusses the legal issues being decided in each of the federal court cases surrounding Remicade.

  • DIA Biosimilars Conference Reveals “More Questions Than Answers”
    DIA Biosimilars Conference Reveals “More Questions Than Answers”

    During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

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.