Coronavirus disease 2019 (COVID-19) altered the workflow in all areas of the health care and life sciences industries. The FDA was not exempt from pandemic-induced upheaval. Meetings of advisory committees, which provide the FDA with expert advice on scientific, technical, and policy matters, were often postponed, and although drugs were still reviewed and approved, significant delays occurred.

From the start of the United States’ response to the COVID-19 pandemic in March 2020 until late summer, 2 biosimilars were 

: Hulio (adalimumab) and Nyvepria (pegfilgrastim). This represented not only an improvement in patient access and affordability of life-changing medications, but also a slowdown in biosimilar approvals.

In previous years, biosimilar approvals had steadily increased. As shown in the figure, the projected trend suggested approximately 12 biosimilar approvals for 2020 and 14 for 2021.

The trend line for biosimilar approvals suggested 2020 would be another strong year for the emergence of these lower-cost therapies; however, just 2 had been approved by the midyear point.

Although other factors came into play, such as patent expirations and product development, it appeared unlikely that the total of 12 biosimilar approvals would be achieved in the final quarter of 2020, and there was even potential for this slower pace to extend into 2021.

There were other reasons why patient access did not improve as expected. Typically, once manufacturers receive biosimilar approval, many face 

 that delay products from reaching the market promptly. These court cases often are purposely filed to interfere with market access to a new product. In some cases, “

” agreements postpone market entry of a biosimilar for many 

The COVID-19 crisis extended these delays because court systems temporarily closed to prevent spread of the virus and reopenings were late or occurred only in stages. Well into 2020, virus hot spots 

 to stall judiciary system operations, adding to the time needed to achieve market access for these new therapy options.

In addition to regulatory and judicial barriers, the overwhelming workflow within health systems also played a role in limiting access to new therapies. When health care facilities are in crisis mode, many components of the reimbursement and education processes, each of which is vital for biosimilar uptake, are hindered. 

Pharmacy and therapeutics (P&T) committees are necessary for ensuring new therapies will be included in the health care facility formulary. From the start of COVID-19, P&T meetings were often conducted virtually or 

 on evaluating emerging therapies for COVID-19 treatment, leaving little time for consideration of other formulary additions. With so much focus on COVID-19, little time was allocated to much else.

Within hospitals, the same was true regarding in-service education for physicians. With a need to educate physicians on current protocol, diagnostics, and treatment surrounding COVID-19, there was not much time left to educate on biosimilar therapies and novel agents.

“Lunch and learn” programs were likely on hiatus during the pandemic due to social distancing requirements, understaffing, and a strain on funding. Gathering professionals into a conference room could not be prioritized over keeping everyone safe.

Typically, many facilities partner with manufacturers to supply marketing materials and food to lunch and learns, and a clinical staff member presents on the topic at hand. As manufacturer field teams were grounded, less information reached the health care providers. Most nonessential visits were prohibited to prevent unnecessary risk of virus spread. These grounded professionals included sales representatives who provide information about new products, field reimbursement specialists who assist in getting products approved by the health plans, and medical science liaisons who can discuss new products on a higher level. These professionals were not as physically active as the pandemic unfolded and virtual methods of interaction were implemented.

If new therapies, including biosimilars, were not approved by the FDA, litigated promptly in the courts, cleared for formulary placement, or explained to physicians, it is unlikely patients were learning much about them. Especially when it comes to biosimilars, patients need to be aware of their potential options and the associated benefit of cost savings. With COVID-19, the nation entered a time of financial instability and loss of health care coverage, and these new therapy options became even more important for safe and affordable health care.

Coronavirus disease 2019 altered the workflow in all areas of the health care and life sciences industries, and the FDA was not exempt from pandemic-induced upheaval.

The Pandemic's Multilevel Effect on Patient Access

Amanda DeMarzo, PharmD, MBA, PACS, is the associate director of Patient Access with the National Board of Prior Authorization Specialists, an affiliate of the Accreditation Council for Medical Affairs, based in Oradell, New Jersey. She focuses on how to improve the current health care system as a whole through improved training, widespread certification, and advanced technology for better patient outcomes. She developed a passion for patient-centered care and shared decision making during patient-facing roles over the last 8 years.

Amanda DeMarzo, PharmD, MBA, PACS

The House of Representatives has approved the bipartisan 21st Century Cures legislation, which includes funding for innovative research and provisions to speed up the drug approval process.

By a vote of 392-26, the House approved the 21st Century Cures Act. The House had passed an earlier version of the bill in July 2015 but continued to revise and update it, releasing the most recent draft of the bill last week. These updates included provisions for mental health, substance abuse, and child and family services.

Members of both political parties have been vocal in their support of the legislation, often citing its passage as a top priority during the lame-duck Congressional session. Prior to the election, Senate Majority Leader Mitch McConnell, R-Kentucky, had said it “could end up being the most significant piece of legislation we pass in the whole Congress." 

House of Representatives Approves Bipartisan 21st Century Cures Legislation

Christina Mattia

Gregory Schimizzi, MD, is a co-convener of the Biologics Prescribers Collaborative (BPC) and the cofounder of Carolina Arthritis Associates, PA, in Wilmington, NC.  He has been a licensed and board-certified rheumatologist in private practice for 30 years. He co-founded, and previously served as president, of the Coalition for State Rheumatology Organizations (CSRO). He has also previously served as president, and a member of the executive board, at the North Carolina Rheumatology Association. Dr Schimizzi completed his undergraduate and medical school studies at Wayne State University in Detroit and completed his fellowship training at the University of California at Irvine.

Gregory Schimizzi, MD

The hunt for biomarkers to add precision to efforts to determine biosimilar equivalence will get an added boost from a 

between the FDA and SomaLogic of Boulder, Colorado.

The agreement involves the use of a highly sensitive protein measurement tool to assess changes in circulating proteins in patient blood samples following treatment with reference biologics. These same measurements will be compared with protein levels in samples from patients using biosimilar drug candidates. This type of large-scale analysis of proteins is called proteomics.

“Circulating proteins, when measured at the broadest scale, provide system-wide information on the dynamic effects of drug exposure-response,” Stephen Williams, MD, chief medical officer at SomaLogic, said in a statement. “Comparing the 'blood protein fingerprint' of a biosimilar to a reference biologic has the potential to be more efficient and precise than clinical observations for establishing biosimilarity.”

The agreement involves collaboration between SomaLogic and the FDA’s Division of Applied regulatory Science.

The FDA has been working to develop and validate the use of pharmacodynamic (PD) biomarkers for use in determining biosimilarity. Greater reliance on biomarkers for demonstrating biosimilarity is considered an avenue to greater accuracy in comparing biosimilars with reference products and also a means of avoiding costly comparative clinical trials, which use parameters of measurement that are less exact and add to the amount of time and expense needed to assemble evidence for biosimilar approval.

SomaLogic noted that the 28 biosimilars approved so far in the United States for a limited number of reference products has been disappointing and proteomics holds out hope for accelerating this process. “Regulatory approval of a proposed biosimilar requires demonstration that it is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product, a process that can take several years. The research at the center of this agreement aims to advance the use of novel tools and approaches that could streamline biosimilar development,” the company said.

The collaboration will span 5 years and, in addition to identifying circulating PD biomarkers, SomaLogic will seek to develop analytical approaches usable for demonstrating that biosimilar candidates are equivalent to their reference products.

If successful, this proteomic strategy could reduce the need for costly and lengthy comparative clinical studies. This, in turn, should streamline the development of biosimilars and thus accelerate delivery of safe, effective, and affordable biosimilar treatments to patients.

The use of PD biomarkers to establish equivalence has been modest at best, authors of a 2019 clinical article 

. In exploring the rationale for developing and using PD biomarkers in biosimilar development, the authors 

 that up until July 2019, PD similarity data had been employed to demonstrate biosimilarity for just 5 approved biosimilars, and these were dose-dependent PD markers: absolute neutrophil count for filgrastim and pegfilgrastim, CD34+ cells for filgrastim, and reticulocyte count and hemoglobin level for epoetin alfa.

A collaboration with the FDA could lead to new forms of pharmacodymamic measurement that improve speed and efficiency of biosimilar development and approval.

SomaLogic Inks Proteomics Deal With FDA for Biomarker Development

Tony Hagen

Entering 2020, we have the opportunity to take a moment, look back, and reflect on the lessons learned of the previous decade with regard to biosimilars. The road to a successful biosimilars market has been anything but straightforward. With complications including a slow rate of approval, extended delays in product launches due to patent litigation, or the small and incremental degree of economic impact, it’s easy to become frustrated and question whether or not biosimilars represent an economically prudent investment in the new decade. 

While I would not argue with anyone that we should expect more from the biosimilars opportunity, simply throwing the baby out with the bathwater at this point would be a monumental mistake that fails to see the growing opportunity the space provides us. Essentially, these hurdles are not as insurmountable as they appear and can be managed if we focus our approach at the appropriate obstacles and recognize the benefits to continued biosimilar development beyond simply the primary goal of lowering the price of biologic drugs. 

The Elephant in the Room: What is a Fair Price?

While the question of pricing is critically important, we must also acknowledge the other structural and economic realities of drug prices. One prominently articulated alternative to biosimilars is the implementation of pricing regulation for biologics after they reach the end of their exclusivity period. This approach would attempt to establish a “fair price” at which an originator biologic will be sold that is intended to include all of the expenses associated with biologic development and the ongoing supply of that product. However, there are several issues with this concept that should be addressed:

Given the current political landscape, it appears rather remote that agreement on a price setting process for biologics or any other pharmaceuticals could be established within the near future.

The creation of this “fair price” would require a degree of transparency from the pharmaceutical industry far beyond anything that presently exists. Currently, there are little if any details concerning the true cost of drug development, high quality manufacturing, and consistent supply. 

The most challenging aspect of this endeavor would be establishing an agreed upon definition of a “fair price.” Given the number of stakeholders involved in and impacted by the pricing of pharmaceuticals, it appears highly unlikely that these participants would agree to a threshold for profit generation.

Realigning our Understanding of Biologics, Generics, and the Concept of Cost

Much of the recent frustration with biosimilars stems from our previous experience with generics. Over the last 35 years, generics have demonstrated that competition can drive dramatic savings with the value being recognized almost immediately. The simplicity of the molecules and the well-established mechanism of declaring products interchangeable, creates a clear pathway for competition. However, the US healthcare market is now closing in on the second decade of a drug shortage crisis that has primarily centered on the persistent and extended interruptions in the supply of hundreds of generic medications.

As a result, we must re-examine our traditional perspective that it is always easy to create generic drugs and always hard to create biosimilars. We have learned that all pharmaceuticals require a great degree of due diligence and commitment to quality. Perhaps the modest barriers to generic entry have been too low to ensure a long-term and consistent availability of high-quality small molecule drugs. Rather than stopping biosimilar development, we should use this ongoing experience to improve our understanding of safe, effective, and sustainable manufacturing for all medications.

A Holistic Approach to Enter the New Year

We are still early in the biosimilars experience and are continuing to make strides in addressing many of the challenges that have slowed and diluted the extent of financial impact. Even with these challenges, the future of biosimilars looks exceedingly bright. According to a report by Global Market Insights, by 2025 the global biosimilars industry is poised to surpass a valuation of $69 billion. However, that will be merely a dream if we are unable to address those hurdles. So what are our next steps? 

Physicians and other clinicians need to understand the concepts of risk management to avoid unnecessary apprehension. If clinicians become more comfortable with the analytical characterization methods to monitor changes in biologics, we move closer to a day when redundant clinical studies are no longer required.

The manufacturing of biosimilars must be monitored closely to avoid any negative impact on product quality. An increased degree of scrutiny of small molecule drugs, including generics, is also important.

We must continue to leverage our advocacy capabilities to remove additional barriers such as the use of excessive patenting to delay the introduction of competition.

Long-term resolution to our challenge of lowering the cost of medications must at some point address the way in which providers are reimbursed. As long as physicians and other providers are reimbursed in a way that higher acquisition costs lead to larger reimbursement opportunities, acceptance of competing products, biosimilars or other, will continue to be limited.

Hurdles to a vibrant biosimilar market are not as insurmountable as they appear.

Understanding the Risks, Opportunities, and Prospects of Biosimilars in 2020 and Beyond

Steven Lucio, PharmD, BCPS

Mauricio Rubio is a pharmacist with advanced studies in administration, and he is currently a master of business administration candidate. He has 13 years of experience in sales, marketing, and business development in Latin America for pharmaceutical and consultancy companies. He has participated as a speaker in the Jack Leckerman Biosimilars Forum in 2018 and 2019.

Mauricio Rubio

Despite legislation designed to facilitate biosimilar competition, “structural challenges” have hindered adoption of these money-saving drugs, and several policy initiatives could spur faster and wider biosimilar use in the United States, according to the philanthropic advocacy group 

In a health policy brief, Arnold Ventures suggested multiple policy changes the FDA, lawmakers, and CMS can implement to expand access to biosimilars and promote more savings. These include changing the biosimilar naming convention, easing requirements for biosimilar approval, stimulating biosimilar use with higher reimbursement policies, and proactively investigating anticompetitive practices, the group said.

Early estimates of achievable biosimilar savings from 2017 to 2026 ranged as high as $150 billion, according to the report.

“Actual uptake has lagged behind these savings estimates. By the end of 2018, seven biosimilars had launched in the US market, but sales for these products [represented] less than 1% of all US biologic sales volume,” the report said. There are 28 approved biosimilars and 18 launched biosimilars in the United States. By comparison, over 60 biosimilars have been authorized in Europe, and according to Arnold Ventures, these are marketed at discounts up to 70%.

In the United States, barriers such as excessive product patenting, deliberate misinformation surrounding biosimilar equivalence, and restrictive payer formularies combine to prevent biosimilars from achieving the success that generics have seen. In the United States, generics accounted for 90% of prescriptions and saved nearly $300 billion in 2018, according to Arnold Ventures. Specialty drugs, which include biologics and biosimilars, currently account for 43% of medicine spending, according to 

In particular, the brief calls on congressional leaders to work with the FDA to discuss whether factors distinctive for biosimilars, such as random-letter name suffixes and interchangeability designations, are even necessary, given that they are not required for other types of drug products. The authors argue that these requirements can create confusion among patients and providers about biosimilars.

 have shown that 4-letter suffixes to distinguish biologics from one another can cause patients to perceive biosimilars as less similar to original brand drugs and affect their willingness to use them.

, which allow for greater access to biosimilars by allowing them to be switched with originators at the pharmacy counter, may require biosimilar manufacturers to perform costly and lengthy switching studies.

On a state level, policymakers need to guarantee that substitution laws give pharmacists flexibility to exchange expensive biologics for cheaper biosimilars without needing to seek permission from a physician, the Arnold Ventures report said.

The brief also said that Congress could direct the Federal Trade Commission to investigate anticompetitive practices used by originator manufacturers, including pay-for-delay deals, rebate traps that discourage biosimilar uptake, and misleading advertising about biosimilars.

The group also recommended that Congress increase reimbursement for biosimilars under Medicare Part B or require that biosimilars be used before costlier formulations. A version of this concept has been proposed in the Senate (

) and would provide a temporary reimbursement increase of 2% over 5 years for biosimilars.

The group said the FDA should evaluate whether biosimilars are being be held to higher standards than originator products, such as requirements for additional switching studies to demonstrate biosimilar interchangeability with reference products.

Arnold Ventures suggests ways the FDA and other governmental entities can get more biosimilars into circulation, faster. 



Advocacy Group Details Solutions for Sluggish Biosimilar Uptake 

Skylar Jeremias

Carlos Sattler, MD, is the head of clinical development and medical affairs at Sandoz, Inc. In this capacity, Sattler leads efforts in the United States to develop and implement Sandoz’s medical and scientific strategy, medical education and communication initiatives, and data-generation activities in support of biosimilars and other Sandoz products. Sattler specialized in pediatric medicine and is subspecialty trained in pediatric infectious diseases.

Carlos Sattler, MD

In 2006, the European Union approved its first biosimilar drug. Now, more than a decade later, the United States and its FDA continues to struggle with how to incorporate these unique pharmaceutical treatments into mainstream medical practice. The complex and organic nature of these biological drugs makes it difficult to test and approve them in a traditional setting—biosimilar treatments will need to gain some degree of acceptance in at least 1 of 4 distinct medical and scientific communities before they can enter the mainstream. Physicians, pharmacists, patients, and health plans will play key roles in the eventual uptake of biosimilars by the broader marketplace, and each population must be reached in a very targeted way.

Perhaps the biggest obstacle to biosimilar uptake is the broad lack of familiarity with these medicines in most disciplines. For 

, despite the fact that biologic and biosimilar drugs have played a vital role in cancer treatment over the past decade in Europe, a 2011 survey of oncologists in found that about 1 in 4 doctors had never heard of biosimilar drugs and more than half admitted that they had “no or slight familiarity” with these treatments.

“People are not going to purchase or prescribe something they do not understand,” said Joseph P. Fuhr, Jr, PhD, professor emeritus at Widener University and member of The Center for Biosimilars editorial board.

“We have a lot of work to do on education,” added Molly Leber, PharmD, BCPS, FASHP, a manager of medication policy and formulary management in the Yale New Haven Health System who also serves on the editorial board at the Center for Biosimilars. “There are numerous surveys that have shown healthcare professionals and patients don’t know about the current drug approval process [for biologics] and even less about biosimilars.” Leber added that many healthcare professionals still have concerns about the safety of biosimilars because of the general lack of awareness about the approval process, and that patients often do not realize that there are alternatives to their current biologic therapies.

While the expanding presence of oncological biosimilars and biologics in the US marketplace will bring these drugs more to the forefront of the prescribing physician’s mind both in oncology and elsewhere, there are certainly some roadblocks to overcome before they become anything other than a last resort. Many physicians who are familiar with biosimilar and biologic drugs still tend toward prescribing more familiar treatment options because biosimilars feel risky; a biosimilar’s corresponding biologic often bears the full weight of testing and trials with the result that the “confirmatory trials” for biosimilar safety required by the FDA may feel inadequate. It is, in fact, the case that for biosimilars the weight of proof of safety and efficacy lies largely within the proof of similarity to a biologic. Further complicating the prescription process, because biosimilars are organic and their effects may evolve in a patient who takes them over time, physicians may be reluctant to prescribe a treatment that feels unpredictable to both the patient and themselves.

 Brian Lehman, MBA, MHA, RPh, manager of pharmacy benefits and policy in Columbus, Ohio, also on the editorial board for The Center for Biosimilars, described the oncology sector as one most likely to be impacted in the near term by biosimilar uptake. “The oncology community is currently impacted by the biosimilar Zarxio (filgrastim) that has been available on the market since September 2015,” he observed. Zarxio bolsters the immune system and helps a patient’s body overcome infection. Lehman further noted that there are 3 additional biosimilars in the oncology pipeline: those for Neupogen, Neulasta, and Procrit/Epogen. “The biosimilar pipeline is robust,” he said, adding, “the FDA has 66 biosimilar 

Furthermore, given that oncology drugs are “some of the highest-priced drugs available,” as Fuhr described them, the introduction of biosimilars will likely “increase access and improve quality of life for many patients,” he said.

In order to reach the prescribing population and generate momentum for biosimilar uptake in this sector, physicians must understand how valuable these drugs may be from both a treatment standpoint and an accessibility standpoint. While effective treatment is certainly vitally important, the relatively lower cost of biosimilar drugs will, of necessity, also play a role in their uptake. However, there is some debate about how affordable biosimilar drugs will actually be compared to their biologic counterparts. “Lower prices and greater access will benefit consumers and help decrease prices in the healthcare market,” observed Fuhr, adding that this will also motivate “innovators” to “attempt to find new drugs as profits on old drugs decline.”

Lehman agreed, stating, “The greatest benefit [of biosimilar uptake] would be increasing patient access to more affordable life-changing and even life-saving biologic drugs.”

Not all sources agree that biosimilar uptake will lead to more affordable treatments, however. Currently, biologic drugs account 

 about 62% of Medicare spending in the United States, compared to about one-third in 2005. It is to be hoped that biosimilar treatment options might make biologic results available to populations that either might not be able to afford them or that might not be prescribed to them first due to cost issues. This in itself presents another uptake issue, however, since conventional wisdom 

 that biosimilar drugs should cost about 30% less than their biologic counterparts but, thus far, these drugs are debuting at more of a 15% discount. This is due, in large part, to the costs of testing and proving similarity of these drugs.

Over the next 4 years, a large number of biologic patents will expire, expanding biosimilar development and production options. This could increase competition in the marketplace and drive biosimilar prices down to that benchmark 30% discount. If it does not, however, physicians and government bodies that fund many of their prescriptions will continue to find it difficult to prescribe these treatments when more conventional options exist.

Pharmacists and Biosimilar Interchangeability

Along with the prescribing community, pharmacists could play a major role in the uptake of biosimilar drugs that receive an FDA approval for interchangeability. For example, in Great Britain, the British Oncology Pharmacy Association (BOPA) has 

 a “welcome statement” to biosimilars that states, in part, that biosimilars can and should be used in place of more expensive biologic treatments when possible. For example, according to BOPA, Rituximab, a biologic used to treat non-Hodgkin’s lymphoma, currently costs the country’s National Health Services about $209 million each year. Medical economists speculate that a biosimilar to Rituximab could save what BOPA called a “significant” amount of money that could be “reinvested into innovation and patient services.” In the United States, a similar attitude from healthcare law- and policy-makers will play a huge role in whether or not pharmacists are willing, when possible, to prescribe a biosimilar in place of the reference biologic.

“The best-case scenario would be if biosimilars can be incorporated into the healthcare system the same way that generic drugs are,” said Leber, elaborating that this would enable biosimilars to create the cost-savings their proponents say will come with their uptake: through competition. She added, “If you look at the European experience, there has been a significant decrease in the drug cost and increase in prescription volume.” Lehman agreed, observing, “Ideally, biosimilars will provide significant savings relative to the cost of the reference product, but there is also a need to balance and monitor for the potential and unintended consequence of discouraging some manufacturers from bringing more biosimilar competition to the US market.”

At the end of the day, it may well be the patient population that is most receptive to biosimilars because their concerns are less complex than those of prescribers and pharmacists. In one particular biosimilar 

, researchers asked the question: “Would you use [this biosimilar] for your mother if she had ERBB2-positive breast cancer?” They concluded, “The answer should be ‘yes.’” The patient population will ultimately be concerned with 2 main issues regarding biosimilars: efficacy and affordability/accessibility. Manufacturers may opt to reach past physicians and pharmacists directly to the patient population in order to solicit requests from patients for these treatments and to smooth the prescription process for physicians. If patients requiring these treatments can be educated about their efficacy, safety, and affordability, then many roadblocks in other populations are likely to erode on their own.

“Patients need education in order to feel confident that a biosimilar is just as safe and effective as the reference product,” said Lehman, citing European 

 including “over 400 million patient days of safe and effective treatment using biosimilars since the first biosimilar was approved and marketed in 2006.”

 Although acceptance of biosimilars in the medical marketplace is largely an issue of educating the appropriate populations about biosimilar topics most relevant to them, there is one potential roadblock to uptake that is largely administrative yet possibly far more substantial than any other: 

. It is not accurate to equate biosimilars to generics in terms of their associated biologics, although it may be helpful to do so to a limited extent when attempting to educate the general public about them. Because biosimilars are not generics of biologics, however, they are difficult to name and track within the medical billing system. At present, when a drug enters the mainstream and physicians begin prescribing it, the long-term effects of that drug can, to a degree, be tracked through the medical billing system. Data in the system can be reviewed to examine effects on subpopulations of patients and potential problems and benefits may be identified. However, biosimilars cannot be named the same way as generics, which have names that link them back to the brand-name drug, and also have a four-letter suffix that, according to the FDA, has no meaning other than that it is unique to that specific biosimilar. This will prevent inadvertent substitutions and support safety monitoring, but it will dramatically complicate how the drugs are processed through medical billing and could inhibit prescribers’ and pharmacists’ willingness to promote biosimilar use. “Formulary decisions are going to be complex,” Leber warned.

If biosimilar uptake does not gain momentum in the next decade the entire biosimilar industry could be derailed. In the event that it is too expensive to bring these treatments to market and achieve uptake in the medical sector, manufacturers may opt to pursue other treatment models. Of course, runaway successes of biologics like Genentech’s 

 (omalizumab), a treatment for allergic asthma that became a blockbuster drug in 2014, could entice manufacturers to continue research and development as long as the biosimilar industry continues to evolve in the public eye and the view of the medical population.

Biosimilars are demonstrably safe, effective, and affordable relative to their biologic counterparts. Conveying that message to the various stakeholders: physicians, pharmacists, and patients, is the linchpin to biosimilar uptake in the United States in the next decade.

Who Will Influence Biosimilar Uptake: Physician, Pharmacist, Patient, or Payer?

Carole Ellis

As of today, March 23, 2020, the life sciences industry completes “the transition.” New categories of biologics will now be licensed via the biologics approval pathway under the Biologics Price Competition and Innovation Act (BPCIA). 

This transition occurs 10 years after the 2009 enactment of the BPCIA. During that interim, manufacturers of certain biologics approved and under review for approval were in limbo as to how their products and rights of exclusivity would be treated under the new policy.

 previously approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FDC) will automatically be “deemed” biologics licensed under section 351 of the Public Health Service Act (PHS). Ultimately, these drugs will be categorized as biologics, subject to biosimilar and not generic competition.

Unfortunately, the original BPCIA statute did not provide instructions to the FDA on how to implement this change. Therefore, the FDA has taken certain steps to enact the transition via several proposed rules and the implementation of its 

The BAP was released in July 2018. The plan is in 2 sections. The first defines key areas in which the FDA wants to focus its regulatory efforts: improving clarity and efficiency of the biosimilar approval process, enhancing understanding through better public communications, and addressing anticompetitive practices.  

The second section is made up of key actions. These are steps that the FDA is either taking or planning to take to improve review processes, create information resources, upgrade guidance, and encourage public feedback. Many of these actions have already been initiated.

On February 21, 2020, the FDA released a 

 that goes into effect today. It amends the FDA’s regulatory definition of a biological product so that it is aligned with the BPCIA. “Under the final rule, the term 

means any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.” This is one of the final steps in the 10-year transition process. It opens the door for insulins to be approved via the biologics license application (BLA) pathway.  

Over 100 products that had been approved via new drug applications under the FDC now must be reviewed as BLAs under section 351 of the PHS. Drugs that will be transitioned include naturally occurring proteins such as hyaluronidase, human growth hormones, and menotropins.

The FDA is focusing on insulins and has made waves with the release of 

 The FDA indicated that switching studies may not be needed for a designation of interchangeable insulins if analytical assessments suggest high similarity between biosimilars and reference products. This could speed the arrival to market of the first interchangeable biosimilars in the United States for insulin.

The FDA has also released 2 question-and-answer documents that discuss the transition for 

. With the BAP and guidance, the FDA has signaled that they are moving forward with the transition as a means of introducing more affordable medicines into the healthcare system—specifically, by expanding the use of biosimilars.

As of today, the FDA has completed a 10-year process to bring a wider set of biologics under the biologics license pathway for approval.
 

Authors