• Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise

    With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.

  • FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities

    On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.

  • The BPCIA And Declaratory Judgment: The Real Dance Partners?

    In theory, the initial exchange process in the first phase of litigation is intended to whittle down the number of patents and initiate resolution of any disputes during FDA review of the aBLA. However, despite its high-minded objectives, litigation under the BPCIA has proven less harmonious than planned. 

  • The Opportunities & Challenges Of India’s Biologics Market

    Biosimilar drugs, due to their affordability, can play an important role and allow the Indian government to have a better healthcare system. However, as issues remain on the regulatory and manufacturing sides, India needs to see strong improvements to compete and appear as an important hub nationally and internationally.

  • Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?

    In this fourth installment of the Editorial Board 2021 Outlook, it's clear that stakeholders are relying more heavily on biosimilars and that it’s more important than ever for biosimilar companies to keep carrying the torch for more competition, cost-savings, value, and responsible pricing.

  • The Biosimilar Toolbox: How To Ratchet Up Biosimilar Competition In 2021

    As you’ll read in the following responses, increased competition in 2021 is on the minds of many. How that competition unfolds has yet to be determined. But if one thing is clear, it’s that the industry has many exciting tools at its disposal to bolster biosimilar competition in 2021. 

  • The Top 5 Biosimilar Developments Of 2020

    Though 2020 felt like an endless descent into Dante’s Nine Circles of Hell, I wanted to end the year as I typically do: with a column highlighting the most important and positive biosimilar developments from the past 12 months.

  • The Second Wave Of Biosimilars: New Scenarios, New Rules

    The arrival of what we could call the first “bio patent cliff” has revealed important lessons that should be taken into consideration when selecting new candidates for the second and third waves.

  • Biosimilar Experts Reflect On 2020’s Greatest Biosimilar Achievements

    As the amazing members of the Biosimilar Development Editorial Board emphasize here, there is a lot to be thankful for in the biosimilar world. Check out the first of what will be a four-part series showcasing the editorial board’s thoughts on the past year and the year(s) ahead.

  • Why Severability Should Be Every Biosimilar Makers’ Rallying Cry In 2021

    In the upcoming months, the Supreme Court will (hopefully) be deciding whether Congress intended for the entire ACA to survive should individual provisions be found unconstitutional. So, for better or worse, the biosimilar industry has a few more months of pondering the (excruciating) “what ifs” around the future of the BPCIA. 

  • The Little-Known Drivers Behind 2020’s (And 2021’s?) Biosimilar Boom

    There were a few efforts discussed during the recent DIA Biosimilars Conference that I wanted to single out as being particularly critical to the inner workings of this market. I’d argue these efforts are just as noteworthy —perhaps even more worthy — of celebrating as biosimilars’ resulting market performance. 

  • Federal Circuit To Decide Limits On Functional Claiming Of Isolated Monoclonal Antibodies

    Can a patent claim millions of different antibodies based on their function alone? Tens of thousands? Hundreds? What if the patent gives a plug-and-play road map to make and evaluate the antibodies through routine testing? Whatever the CAFC’s answer, one thing is sure: It will affect how biologic innovators use functional claiming and whether patentees or challengers are more likely to win future lawsuits in the biologics and biosimilar arena. 

  • The Intriguing FDA News You May Have Missed

    In recent weeks, The Biosimilars Forum announced via press release that it had submitted commentary to the FDA’s notice entitled, “Examination of Secondary Claim Disclosure and Biosimilar Disclosures in Prescription Drug Promotional Materials.” Here’s what you should know about the FDA’s latest notice.

  • Rituxan Biosimilars In The Real World: Market And Clinical Considerations

    Following publication of the Future Oncology paper, I connected with one of its co-authors, hematologist Dr. Chadi Nabhan, to hear his thoughts on how biosimilar rituximab will integrate into the standard of care (especially in the face of novel lymphoma therapies), and how he envisions a real-world approach for rituximab and other oncology biosimilars taking shape.

  • Oncology Biosimilars: Prepare For A Non-Buy & Bill World

    Given the financial toxicity and evolutions in oncology reimbursement models, one physician argues that the biosimilar discussion needs to evolve in a few key ways.

  • Cardinal Health Biosimilars VP Reveals Goals For Improving Rheumatology Uptake

    Following a new Cardinal Health survey on biosimilars in rheumatology, Cardinal Health's VP of biosimilars shared how she plans to use the survey findings as a jumping off point for Cardinal Health (with its manufacturing partners) to improve biosimilar education and engage the rheumatology community.

  • How This Biotech Aims To Become A Biosimilar “Rock Star” In South Africa

    As you can imagine, getting established as a biotech boasting a unique expression system comes with its own set of challenges — especially when trying to enter a nascent biotech space in an emerging market. Here, one CEO discusses the strategies his company is exploring to gain buy-in on the company’s long-term goals in South Africa.

  • Biosimilar Competition: Not Your Grandmother’s Generics Market

    To better understand the payer dynamics taking shape in the increasingly competitive oncology space, I spoke with Biosimilar Development editorial advisory board member Kathy Oubre. Here, she highlights the changing dynamics she is observing on the payer front and shares the impact these can have on oncology practices and oncologists’ overall use of biosimilars.

  • The Case For Optimism In The U.S. Biosimilar Market

    In the U.S., it is estimated that biosimilars can save the healthcare system approximately $150 billion over the next five to 10 years. In this op-ed, Amgen's Chad Pettit shares why the U.S. has cause to be optimistic about the competition emerging in the U.S. 

  • The Proposed Biosimilar Shared Savings Model: A Closer Look

    Following publication of his recent white paper, I touched base with Alex Brill to better visualize what a shared savings program might look like for biosimilars and to unpack the questions and challenges facing CMMI in establishing such a program.

  • Biosimilars In Rheumatology: How To Move The Needle On Uptake, Access

    In this Q&A, one rheumatologist talks through some of the biggest takeaways he had from a recent Cardinal Health survey and how rheumatologists, manufacturers, and payers can better move the biosimilar industry forward for patients.

  • 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.

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.  

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