• Maybe Biosimilar Applicants Should Dance After All

    The decision to engage in the BPCIA patent dance with a reference product sponsor is rarely black and white. Early dismissals in cases like Eagle v. Slayback and Amgen v. Coherus are just one factor a biosimilar applicant should consider.

  • 3 P’s In A Pod: Keys For Building A Successful U.S. Biosimilars Market

    In listening to several speakers during a BIO Digital panel, these three talking points added some clarity to the slowly growing discussion on what U.S. biosimilar success will look like.

  • Why It’s Time For A U.S. Biosimilar Shared Savings Model

    There's been much discussion about launching a biosimilar shared savings program through the CMMI. In this Q&A, Biosimilars Forum president Julie Reed discusses why this is the best path forward for the U.S. and how The Forum and its members are preparing to ensure its success. 

  • How Canada Built A Framework For Biosimilar Transitions In Its Provinces

    Two experts from The pan-Canadian Pharmaceutical Alliance and Cancer Care Ontario discuss the efforts they undertook and challenges they still face in establishing consistent cross-province implementation policies for biosimilars.

  • Canada’s Nuanced Healthcare System: Biosimilars In The Private Sector

    The first of this two-part article portrays the complex makeup of the Canadian healthcare system and current stakeholder needs as it relates to biosimilar switching, with a specific focus on the results of one private payer's transition program.

  • Biosimilars In An Election Year: What To Expect

    Christine Simmon, the executive director and SVP of policy and strategic alliances for the Biosimilars Council shares several leading biosimilar policy efforts that are front-of-mind for the Council, paying a closer look, as well, to some of the potential limitations of the proposals as they stand now.

  • Aligning With Cancer Centers To Spur Biosimilar Uptake

    During our conversation, Pontchartrain Cancer Center COO Kathy Oubre shared what biosimilar makers can do to balance both sustainability and promote cost savings while also supporting cancer centers and their healthcare professionals.

  • Biosimilars In The Pandemic Age: Current Impact And Market Implications

    This has been a very exciting time for those in drug discovery, while it’s been a bit quieter on the biosimilar front (understandably). That said, I’ve come across a few tidbits of knowledge here and there about the impact this pandemic may or may not yet be having on the biosimilar space.

  • Recent Conference Portrays Progressively Sophisticated Biosimilar Market

    As many of the points shared at the recent World Biosimilar Congress suggest, there have been enough big triumphs in the U.S. and other countries that the discussions surrounding biosimilar education and implementation have and will continue to grow increasingly nuanced.

  • 3 Pressing Questions From The FDA/FTC Biologics Competition Workshop

    After taking at least 20 pages of notes from the FDA/FTC biologics competition workshop, I’ve whittled my takeaways down to three overarching questions that provide necessary considerations and industry action steps moving forward. 

  • How Biosimilars, Biobetters Fit Into Value-Based Healthcare

    As the buck falls on physicians and healthcare systems to better control the cost of care, I wanted to hear from Dr. Chadi Nabhan about the value-based care models he’s been watching and how biosimilars (and biobetters) could fit into the overarching goals of these arrangements.

  • How Can Hospitals Lead The Biosimilar Charge?

    One oncology expert shares his thoughts on the operational challenges biosimilars may pose hospitals and what biosimilar manufacturers need to consider as they continue to invest in and launch oncology biosimilars.

  • Sandoz Executives: Have Biosimilars Lived Up To Their Promise?

    I had the fortune of talking with two U.S. Sandoz executives, Sheila Frame, VP, marketing, market access, and patient services, and William Yoon, head, external engagement and medical advocacy. In the first of this two-part article, I picked their brains about the progress they’ve observed and how challenges for the industry have evolved over the past 10 years.

  • 6 Important Elements Of The New STRONGER Patents Act

    Over the past decade, patent reform has been an area of emphasis for Congress, with the passage of The America Invents Act of 2011 (AIA) and, more recently, the filing of a revised version of the STRONGER Patents Act in July 2019.

  • Biosimilar Industry Advancements To Watch In 2020

    Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry.

  • Fresenius Kabi: The Quest For More Efficient Biosimilar R&D

    Following the news of Fresenius Kabi’s new biosimilar R&D lab, I reached out to one executive to discuss the current challenges in biosimilar R&D, including maintaining the delicate balance between biosimilar R&D and commercial teams as Fresenius Kabi prepares for a long future in the biosimilar space.

  • The Top 7 Biosimilar Developments of 2019

    I normally only do the top five developments for the biosimilar industry in this annual column. But it turned out, upon reflection, that 2019 was an even more eventful year than it may have seemed as we were making our way through. So, you’re getting a whopping seven this year.

  • What Does 2020 Hold For Biosimilars? Industry Experts Weigh In

    As we face 2020, several big questions remain from the past year and about what the future may (or may not) bring for the industry. Here, these 19 experts pose their biggest questions for the new year, as well as how they anticipate or hope these questions could be answered.

  • Biosimilar Industry Experts Highlight 2019 Triumphs, Tribulations

    As we close out another year of global biosimilar successes and twists and turns, it’s always important to take stock on just how far we have come and where we still hope to go as an industry. As in years past, I reached out to members of Biosimilar Development’s editorial board and several other experts to get their take on the past year's progress.

  • Inside FDA’s Latest Biosimilar “Game Changing” Guidance

    Overall, there are three broad takeaways to both celebrate and consider about the FDA’s latest clarification of the biosimilar regulatory pathway as it relates to insulin biosimilars.

  • CMS Star Ratings: Will Biosimilars Benefit?

    The Centers for Medicare and Medicaid Services (CMS) star ratings system was created in 2007 for insurance plans operating under both the Medicare Advantage and Part D. This 1 to 5 system (with 5 being the highest rating) is a way for CMS to measure the value of a plan and determine whether to continue to allow it to be part of the program. However, it’s more than just the plan, since the plan’s providers play a key role in how CMS evaluates each plan.

  • Biosimilar Competition Is Here To Stay In 2020

    Following Peter Bach’s controversial argument to “throw in the towel” on biosimilars, I reached out to three economic experts for their perspectives on how to create a functioning, competitive biologics marketplace and which economic and government policies will be the best to pursue for long-term success.

  • The Biologic, Biosimilar Insulin Transition: The Patient Perspective

    In this article, a patient advocate from the JDRF shares the diabetes community’s perspective on the upcoming regulatory transition of insulins and how the industry can better engage and educate patients about the future presence of insulin biosimilars.

  • Real-World Evidence & Biosimilars: Weighing The Potential Impact

    Here, IQVIA’s Jaclyn Bosco, Sandoz’s Edward Li, and the University of Messina’s Dr. Gianluca Trifirò discuss how RWE can impact regulator and payer decisions, shape treatment pathways, and encourage greater stakeholder comfort and action toward biosimilars.

  • Biosimilars: Lessons Learned From Regulatory Approvals

    This article, based on the EMA’s European public assessment reports (EPARs) and the FDA’s BLA (biologics license application) reviews, identifies many inconsistencies that require revision of regulatory guidance to ensure faster approval of biosimilars.

  • Transition Biologics: FDA, Industry Examine Regulatory Nuances

    Though these experts all believe this transition should go off without a hitch and will not hinder insulin access, there are several overarching regulatory and educational considerations the industry should be aware of as March continues to creep closer.

  • Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers

    The clock is ticking for state lawmakers to preserve an existing law that allows for prescription drug coupon usage in Massachusetts with an end-of-the-year deadline fast approaching.

  • Can The FDA Salvage Interchangeable Follow-On Biologics?

    Learn the statutory and regulatory requirements for interchangeability designation, how the designation hampers follow-on biologics, and why the FDA should loosen requirements for the designation.

  • EU5 Biosimilar Adoption: What Can The Past Tell Us About The Future?

    In this article, we review the penetration of biosimilars in the top five EU markets, with special emphasis on the years 2016 and 2018, as well as the key elements that could explain these results. The survey focuses on 23 of the 57 approved products for which we have data from at least 18 months in the five markets.

  • EMA Update: What Challenges Are Biosimilars Bringing To The Table?

    One EMA regulator brought up several points at a recent conference that stood out, either as bright spots to boost industry morale, or that emphasized where the industry needs to focus its energy to pave the way for future regulatory reform.


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.