• 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.

  • Will Authorized Biologics Disrupt The Market For Biosimilars?

    The small molecule generic drug market and the current biologics/biosimilar market are ultimately not directly comparable. However, it's instructive to analyze how authorized generics impact the small molecule space to predict how authorized biologics may impact the biosimilar/interchangeable market in the future.

  • WHO Elaborates Upon Biosimilar Prequalification Progress

    One technical expert from the WHO outlined the current requirements for the two pathways for biosimilar prequalification and the progresses and pitfalls for companies seeking a spot on the WHO’s list of prequalified medicines.

  • Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes

    Once again, Congress has its eyes on the pharmaceutical industry. Legislators from both parties have been active in proposing new legislation that could impact biologics and the market for biosimilars in the United States. Although these proposed bills have taken a variety of approaches, they are principally focused on market access and pricing of biologic drugs.

  • What Incentivized These Oncology Clinics To Embrace Biosimilars?

    I reached out to Dr. Jeffrey Patton, the CEO of Tennessee Oncology and president of physician services and board member at OneOncology to better understand the overall decision to implement Amgen's Kanjinti and Mvasi biosimilars, as well as which mechanisms he believes will help improve biosimilar usage in oncology in the months and years ahead.

  • Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time

    In this second part of a two-part series, we’ll dive into some of the details and datasets behind pharmaceutical pricing, trends, and behaviors in an effort to move toward effective cost management, economic sustainability, and continued U.S. pharmaceutical innovation.

  • Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.

  • FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics

    While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

  • A Delicate Balance: Patent Exclusivity, Innovation, And Competition

    Overall, arguments calling into question the value of biologics competition tie into what I think is an even more important question worth asking in this country: What global responsibility does the U.S., as the largest pharmaceutical market, have in terms of promoting greater access to medicines?

  • Do The Arguments For Pharmaceutical Price Increases Make Sense?

    This article will share recent analysis of price increases within the healthcare sector in an effort to understand the growth of healthcare expenditures and pharmaceutical prices over time.

  • Breaking Down Amgen’s Win In The Biosimilar Enbrel Patent Fight

    Following a trial in the District Court of New Jersey, Sandoz has been barred from marketing a biosimilar version of Amgen’s Enbrel product. Due to the scarcity of biologics patent case rulings, this case provides an interesting precedent for how future decisions may treat biologics patent issues.

  • FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis

    This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).

  • Stakeholders To Gather In D.C. To Discuss U.S. Biosimilar Market’s Future

    Prior to the DIA Biosimilars Conference, I wanted to catch up with speaker Julie Reed of Pfizer to see what she’s most excited about imparting to attendees and what she hopes to learn from the upcoming conference.

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.  

#ONBIOSIMILARS