• 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.”

  • Pfizer’s Cultural Evolution To “Tell The Biosimilar Story”
    Pfizer’s Cultural Evolution To “Tell The Biosimilar Story”

    Pfizer's Tracy Dianis presents a candid look into the cognitive and cultural transition that needed to occur in her own mindset, as well as within Pfizer, in order to embrace biosimilar development.

  • Biosimilar Regulatory Best Practices: Don’t Fear Exploration
    Biosimilar Regulatory Best Practices: Don’t Fear Exploration

    In the first of this two-part article, Sandoz's Cindy Cao shares lessons learned from working with the FDA and reveals that there is still a lot of room for exploration and innovation in biosimilar development.

  • How Can Biosimilars Remain Politically Relevant?
    How Can Biosimilars Remain Politically Relevant?

    What does the biosimilar industry need to do now to ensure it’s a relevant and central part of current and future healthcare reform?

  • What These Two Mottos Must Mean For The Biosimilar Industry
    What These Two Mottos Must Mean For The Biosimilar Industry

    I recently attended the Association for Accessible Medicines (AAM) Biosimilars Council’s Leading on Biosimilars conference.In addition to the many tidbits of knowledge I took away from this event, two terms kept resurfacing throughout the conference I feel are worth delving into more deeply.

  • The Evolution Of Russia’s Biosimilar Regulatory Pathway
    The Evolution Of Russia’s Biosimilar Regulatory Pathway

    In a recent article, I discussed the market opportunities and reimbursement system in Russia. But in addition to this snapshot of the market, my conversation with BIOCAD's Roman Ivanov highlighted how the Russian biosimilar regulatory system was established, as well as the challenges BIOCAD has faced during it evolution.

  • Russia’s Biosimilar Market At A Glance
    Russia’s Biosimilar Market At A Glance

    After my discussion with BIOCAD's Roman Ivanov, it’s clear the Russian biosimilar market is a prime example of the positive impact biosimilars can have on a nation. However, Russia's biosimilar market has evolved quite differently than those of the EU and U.S.

  • Plant-Based Biosimilar Development Takes Root In Brazil
    Plant-Based Biosimilar Development Takes Root In Brazil

    In June 2017, Canadian company PlantForm announced it was beginning construction for a pilot biologics and biosimilar manufacturing facility in Brazil. Given Brazil’s ongoing efforts to establish a local biotechnology industry, I reached out to learn more about PlantForm’s progress in navigating the regulatory landscape to bring its biosimilars closer to market.

  • How To Handle The Impending Biosimilar Pipeline Boom
    How To Handle The Impending Biosimilar Pipeline Boom

    There is no cut-and-dried approach to launching a biosimilar globally. It comes down to having the right commercial model for the right product in the right channel in the right market.  But knowing what is “right” will be a particular stumbling block for many companies.

  • Building Thailand’s Biosimilar Industry From The Ground Up
    Building Thailand’s Biosimilar Industry From The Ground Up

    As the first of this two-part article revealed, the biosimilar market has undergone several revolutions since the release of the Thai FDA’s biosimilar guidelines in 2013. During our tour of Siam’s facilities, the company’s managing director, Songpon Deechongkit, Ph.D., shared the company’s history, overall biosimilar strategy, and some of the pros and cons of being the first and only biosimilar company in Thailand.

  • The Thai FDA’s Approach To Biologics And Biosimilars
    The Thai FDA’s Approach To Biologics And Biosimilars This article examines Thailand's history with biologics and biosimilars, as well as Siam Bioscience's perceptions of the current Thai FDA biologics and biosimilar regulations in relation to the U.S. and EU.
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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.