Christina Mattina

A study based on claims data and adverse event reports compared the medical costs linked to infections in patients taking 3 different biologics: certolizumab (Cimzia), adalimumab (Humira), and etanercept (Enbrel).

, presented at the ISPOR Annual Meeting in Boston, MA, this week, adverse drug events (ADEs) are a dangerous and common occurrence, as they represent the fourth leading cause of death in the United States and are responsible for 700,000 emergency department (ED) visits per year. However, it can be challenging to determine the medical costs related to ADEs using claims databases.

Researchers from Advera Health Analytics and WEA Trust gathered data from Advera’s analytics platform on ADEs reported to the FDA and compared it to the WEA Trust’s claims database “to determine whether spontaneous ADE reporting analysis could be used as a proxy for claims-based outcomes studies.” They used data from both sources for the time period of August 2013 through July 2015, as well as drug usage information and the medical costs specific to each ADE.

Using the WEA Trust data, the authors determined that certolizumab had a drastically higher rate of associated pneumonia than adalimumab and etanercept (13.6% vs 0.5% and 0.9%, respectively). Not surprisingly, certolizumab was also responsible for increased costs to the healthcare system. Each prescription of certolizumab was associated with $522 in ED costs and $156 in hospitalization costs, about double the expenses associated with adalimumab ($256 in ED costs and $79 in hospitalization costs). The costs associated with etanercept were the lowest of the 3 drugs, at $190 in ED costs and $57 in hospitalization costs.

The ADE data provided to the FDA confirmed that certolizumab was responsible for significantly more reports of pneumonia. It also indicated that certolizumab resulted in higher downstream costs per prescription from both serious ADEs and patient outcomes than the other 2 drugs. When comparing the costs calculated with claims data to the FDA-reported events, the researchers found that the “per dispense medical cost in the WEA Trust claims data correlated to Advera Health’s calculated downstream medical cost from FAERS [FDA Adverse Events Reporting System] data.”

Tumor necrosis factor (TNF) inhibitors, are widely prescribed to treat autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory disorders. The WEA Trust, an insurer in Wisconsin, plans to use these findings to work with providers so they can modulate TNF-α inhibitor prescriptions to lower cost and improve safety.

In 2016, biosimilars of both etanercept and adalimumab were approved by the FDA. However, marketing of both has been 

, as Amgen’s Amjevita (adalimumab) is being challenged by AbbVie, the maker of Humira. Simultaneously, Amgen is involved in a 

 over Novartis’s Erelzi (etanercept), the biosimilar of Enbrel.

The FDA has not yet approved any biosimilars of certolizumab, although a version being developed by PFEnex is currently in the preclinical stages of the pipeline.

Articles

Certolizumab Responsible for Higher Costs, Pneumonia Rates Than Adalimumab, Etanercept 

The Patent Trial and Appeal Board (PTAB), part of the US Patent and Trademark Office, has ruled in favor of biosimilar manufacturer Coherus, striking down one of the patents protecting adalimumab, sold as Humira (adalimumab) by AbbVie.

The compound patent for Humira expired in 2016, but there are a number of other individual patents protecting specific formulations and dosages of the drug. The PTAB’s recent ruling applies to Patent 8,889,135, which “covered subcutaneous dosing of 40 mg of Humira every 13 to 15 days for treatment of rheumatoid arthritis,” 

. However, rheumatoid arthritis is not Humira’s only indication, and it makes up just one-third of its total use.

Numerous other patents continue to protect Humira from biosimilar competition. For instance, the PTAB denied Coherus’ petition to review another Humira patent, US 9,114,166, in 

. Another Humira patent, 9,085,619, has been challenged through the same “inter partes review” method, and a ruling from the PTAB is likely months away. Any of these rulings can be appealed by AbbVie, 

Still, Coherus plans to forge ahead with its adalimumab biosimilar, currently called CHS-1420, by skirting around the remaining patents. It aims to submit an application to the FDA by summer 2017, and hopes to launch the drug in 2018. Shares of the company’s stock had jumped by 8% hours after the board’s decision, while shares of AbbVie dropped by 2%.

“While more remains to be done, this is a significant step forward to lowering drug costs for patients and healthcare providers in the US system,” Coherus president and CEO Denny Lanfear said 

. “We believe this successful outcome validates Coherus’ leadership in biosimilar intellectual property and the effectiveness of our platform.”

Amgen’s biosimilar to adalimumab is FDA approved, but Amjevita has not yet hit the market as it is hindered by legal challenges from AbbVie. Sandoz’s adalimumab biosimilar is also progressing through the pipeline, as it 

 favorable phase 3 results. Sandoz plans to submit an application for GP2017’s approval with the FDA and the European Medicines Agency sometime in 2017.

Humira’s high revenue makes it an appealing target for biosimilar manufacturers. According to one analysis, the average cost of a yearlong course of the drug reached $27,665 in 2015, representing an increase of almost 50% from its cost in 2012. In 2016, it had $16 billion in global sales. The anti-inflammatory drug is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis.

AbbVie Loses Humira Patent Challenge to Coherus

Considering the current low levels of biosimilars knowledge among many pharmacists, a group of researchers has developed a framework for integrating education about biosimilars into the Doctor of Pharmacy (PharmD) curriculum.

American Journal of Pharmaceutical Education

, suggests that future pharmacists will need to be knowledgeable about all facets of biosimilars, from development to regulation to pharmacy practice laws, especially as more and more biosimilars are approved and enter the market.

Biosimilars teachings, the authors write, could be integrated into the 4 main domains of pharmacy education: biomedical sciences, pharmaceutical sciences, clinical sciences, and social/administrative/behavioral sciences. They proposed 4 “key educational parameters” for biosimilars that could be taught throughout the PharmD program, along with suggestions on how students’ understanding could be evaluated.

This beginner-level concept should be placed in the curriculum within the first year of the program to teach students the definition of a biosimilar and how it differs from a generic drug. Programs should also explain the risks of immunogenicity and the need to carefully evaluate safety data; this knowledge can be assessed with objective exams. “Understanding these concepts will reinforce to the PharmD graduate the importance of establishing pharmacovigilance processes to go along with the medication use processes at their institutions and practices,” the authors write.

How are biosimilars developed and regulated? 

This intermediate-level lesson should be offered in the first 2 years of the 4-year doctoral program, allowing future pharmacists to learn about the biosimilars development process, the FDA’s biosimilar approval pathway, and the data required to demonstrate extrapolation and interchangeability. “Debates surrounding the guidances in draft form by the FDA would reinforce the complex issues of naming, interchangeability, and pharmacovigilance,” according to the authors, by demonstrating that biosimilar policies are controversial.

This intermediate-level lesson would be included in other courses about medication dispensing in order to educate students about the federal and state laws surrounding biosimilar substitution, as the complexities of biosimilars make substitution more difficult than with generic small-molecule drugs. It will also review whether substitution laws apply to pharmacists practicing in non-community settings. The authors write that after presenting these lessons in lectures, “lab-based activities should be developed to ensure that students follow the proper procedures for biologic substitution, in accordance with specific state pharmacy practice laws.”

This advanced-level concept would be taught in context with other clinical therapeutics courses as a way of tying together the previously learned biosimilars information. Students would learn how to deal with biosimilars at the practice level and educate others on their use. The authors write that students could “evaluate the rationale and impact of biosimilars and require them to write policies aimed at reducing medication errors” as well as “prepare comprehensive summaries for an FDA-approved biosimilar and participate in a mock pharmacy and therapeutics committee review for formulary consideration.”

By incorporating these concepts into the pharmacy curriculum, students will graduate with an understanding of the role of biosimilars in pharmacy practice and the ability to weigh their advantages and risks.

“With this education, pharmacists will be able to provide leadership in balancing financial considerations with clinical safety and efficacy considerations in both the pharmacy and therapeutics formulary decision process as well as in the community setting,” the authors concluded. “Ensuring that graduating pharmacists are equipped with the necessary knowledge to manage daily responsibilities with regard to biologics and biosimilars will contribute toward ensuring the appropriate use of these new agents.”

, PharmD, MPH, BCOP, associate professor, Department of Pharmacy Practice, University of New England College of Pharmacy, is also an editorial board member of The Center for Biosimilars.

Framework Proposed to Incorporate Biosimilars Education Into Pharmacist Curriculum 

The European Medicines Agency (EMA), working with the European Commission (EC), has released a guide for healthcare professionals that contains essential information on biosimilars, including evidence supporting their safety and an explanation of the regulatory process.

, the guide was presented at the EC’s 3rd annual stakeholder event on biosimilars, which was attended by providers, patients, payers, and pharmaceutical manufacturers. Juan Garcia Burgos, MD, head of the EMA’s public engagement department, introduced the guide as a “comprehensive reference material” representing “a joint effort to support information and continuous education of healthcare professionals in the EU, and facilitate dialogue with patients.”

Biosimilar uptake in Europe has been significantly quicker than in the United States, as 28 biosimilars have been approved by the EMA since 2006. Still, the information in 

 indicates that some providers may have misconceptions about biosimilars or be apprehensive about prescribing them. 

One section of the guide uses a table to compare and contrast the 2 drug groups and explains why biosimilars are not the same as generic medicines. For instance, with generic drugs it is “generally possible to obtain exactly the same molecule,” while with biosimilars it is “possible to reproduce the molecule to a high degree of similarity due to unique biomanufacturing methods and natural biologic variability.” Biosimilars also must undergo a more rigorous testing protocol compared with generics, including comparability studies and safety and efficacy trials,.

This strenuous regulation of new biosimilars, according to the guide, has contributed to the drugs’ safety. “Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilar medicines and their reference medicines,” the guide says, also noting that none of the biosimilars have ever been withdrawn or suspended for safety or efficacy reasons.

The increasing use of biosimilars could have important implications for drug availability. The lower price point of biosimilars, due to market competition effects and lessened development expenses, can save money for healthcare systems and patients. “Having more treatment alternatives available is expected to improve patients’ access to biological medicines with proven pharmaceutical quality,” per the guide.

In addition to advice on switching and interchangeability, the guide includes tips on patient communication and links to resources for additional information. The European Union has been at the forefront of biosimilar development and regulation, according to the guide, which explains how the EMA’s regulatory framework has been influential in developing approval guidelines in the United States, Australia, and by the World Health Organization.

“Today, biosimilars are an integral part of the effective biological therapies available in the EU,” said professor Guido Rasi, executive director of EMA, in the press release. “Given the role of healthcare professionals on the front line of patient care, it is vital that they have access to reliable information on these medicines: what they are and how they are developed, approved and monitored.”

European Guide for Prescribers Assures Safety and Effectiveness of Biosimilars

 explains why the biosimilar drugs approved in the United States for treating chronic diseases may not result in the expected cost savings and outlines steps that can be taken to increase the market share of biosimilars.

The viewpoint outlines the history of biosimilars in the United States, from the first approval in 2015 to the present day, when 4 biosimilars have been approved for treatment of 23 indications. [The fifth biosimilar was only 

 in the United States.] The biosimilars field is expected to expand significantly in the coming years, as patent exclusivity for biologics accounting for $100 billion in sales per year will expire by 2020.

Observers have hoped that this expansion will manifest in the kind of savings seen with small-molecule drugs, where price decreases by an average 70% in the 2 years after a generic is approved, but the viewpoint explains that biosimilars for chronic diseases “are unlikely to yield widely expected cost savings” for 3 reasons:

Generic small-molecule drugs are better positioned to gain market share due to automatic substitution laws in every state that either allow or require pharmacists to automatically dispense an equivalent generic drug, as long as the prescriber does not forbid substitution. These laws do not apply to biosimilars, so the market growth of biosimilars is not guaranteed, as patients’ prescriptions must be switched from the branded reference drug to the biosimilar.

Payers are unlikely to apply the same formulary management techniques to biosimilars as they have with small-molecule drugs, where the more expensive branded drug is often not covered or costs more for the patient. Insurers have been reluctant to do the same for biologics and biosimilars, as they are apprehensive of potential pushback from patients and physicians. The viewpoint notes that the branded version of infliximab has not been left off from any major formularies in 2017 even though a biosimilar version is being sold at a 15% discount.

The last and most important factor, according to the viewpoint, is that the rebate agreements between drug companies, pharmacy benefit managers, and insurers have created a “rebate trap” in which branded drug makers threaten to revoke the rebates on the reference drug if a biosimilar enters the market at a discount. The rebate trap “ensures that payer total costs actually increase relative to costs prior to biosimilar availability,” and it can only be averted if nearly all the patients taking a biologic drug switch to the biosimilar, which is unlikely.

The viewpoint offers 3 potential solutions to address these 3 obstacles. First, it recommends that more states pass laws allowing pharmacists to substitute biosimilars that have been labeled interchangeable by the FDA, which could “bolster competition, lower prices, and increase biosimilar availability.” Next, it recommends taking cues from Europe, where biosimilars have more successfully penetrated the market, by amending treatment guidelines to recommend biosimilars, approving more biosimilars, and enacting automatic switching laws.

Finally, the viewpoint author writes that legislators in more states should propose laws to encourage drug price transparency, particularly concerning rebates. This would educate patients on how the complex system of rebates influences their course of treatment and ensure pharmaceutical companies are held accountable for price increases.

The author notes that the hurdles encountered by biosimilars are similar to those faced by generic drugs over 30 years ago; now, generic drugs are widely accepted by patients and prescribers as a safe and cost-effective treatment option.

“Once the same is true for biosimilars, the health care system will likely realize significant savings,” the viewpoint concludes.

JAMA Viewpoint Explores Barriers to Biosimilar Uptake for Chronic Diseases

The uncertainty surrounding the fate of Merck KGaA’s biosimilars unit has been resolved, as Germany-based Fresenius Kabi will buy the division for up to €670 million ($729 million).

, Merck chief executive officer Stefan Oschmann confirmed that the company was in “deep talks” to sell the division to a then-undisclosed buyer. At the time, he suggested the biosimilars arm was worth around $1 billion due to a robust pipeline of drugs in various stages of trials, although none have yet reached the market.

This pipeline, along with the biosimilars division’s approximately 70 employees based in Switzerland, will be acquired with the newly announced purchase, according to 

. The development portfolio is focused on biosimilar versions of drugs used to treat cancers and autoimmune disorders, the branded reference drugs of which currently sell for about $30 billion annually.

“The acquired biosimilars assets are an attractive opportunity for Fresenius Kabi to enter this strongly growing and highly profitable segment,” said CEO Stephan Sturm in the press release. Chief executive Mats Henriksson added that the deal will allow the company to “enhance its position as a leading player in the injectables pharmaceutical market and further diversifies its product portfolio.”

Looking to the future, the company anticipates sales to begin by the end of 2019 and grow to the “high triple-digit million” range from 2023 onwards. It will pay Merck single-digit percentage royalties determined by sales of the acquired drugs. Upon closing the deal, Merck will receive €170 million in cash, while the remaining €500 million will be distributed as “milestone payments strictly tied to achievements of development targets.”

Citing the high costs of clinical trials and regulatory requirements, Fresenius Kabi indicated that it does not expect to break even on its €1.4 billion purchase and investment ceiling until 2022, but hopes it will become profitable for the company and its shareholders by the following year.

 described the divestment as a “major step towards strategic alignment of [research and development] resources to healthcare priorities.” It also mentioned that the deal included agreements to ensure continuity through development support and manufacturing services.

“We have increasing confidence in our Biopharma pipeline and this transaction will help prioritize innovative drug development of high quality and first-to-market best-in-disease assets,” said executive board member Belén Garijo in the statement. “The partnership with Fresenius will allow us to exploit our biosimilars portfolio to full potential while granting us a substantial return on prior investments.”

The press release from Fresenius Kabi also announced its impending acquisition of Akorn, Inc, which sells prescription and over-the-counter products in the United States, at a price tag of $4.3 billion.

Fresenius Kabi to Purchase Merck KGaA Biosimilars Arm for €670 Million

After being recently approved in Europe, a biosimilar for the drug rituximab (MabThera in Europe) could result in considerable savings over the reference drug for the 28 European Union countries, according to 

The analysis discusses how using the biosimilar CT-P10 in place of rituximab, could impact both budgets and patients’ ability to access the medicine. CT-P10, sold as Truxima, 

 for all indications of the reference drug, which include cancers like non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL), in addition to autoimmune disorders, such as rheumatoid arthritis (RA). These 3 conditions, which account for 90% of all rituximab consumed in the study setting, were the primary focus of the new budget analysis.

Researchers estimated the proportion of patients with all diagnoses who will receive CT-P10 instead of the branded drug over a 1-year period at 30%. They also calculated the costs for both the biosimilar and the reference based on the list price and annual dose in milligrams of drug required for each diagnosis. Assuming the CT-P10 would cost 70% of what the branded drug does, the projected budget savings in Europe totaled just over €90 million in 1 year. The researchers also projected that these savings would allow 7531 additional patients to access rituximab therapy that year, or a 6.4% increase in patients taking rituximab.

Specifically, 43.3% of the savings would come from the treatment of NHL, while approximately 26.9% and 19.8% would come from treating RA and CLL, respectively. The bulk of the savings (70%) would occur in 5 European countries: Germany (22.8%), Italy (17.7%), France (13.5%), Spain (8.4%), and the United Kingdom (7.5%). Of the 7531 additional patients projected to gain access to rituximab treatment, 2857 would use it to treat RA, 2263 would use it for NHL, and 1624 would take it for CLL, while 787 would use it for a less common diagnosis or an off-label use.

The researchers then modeled potential budget savings and expanded patient access in a 3-year scenario where CT-P10’s market share would be 30% in the first year, 40% in the second, and 50% in the third. They estimated that Europe would save about €570 million in this scenario, which would allow 47,695 more patients to access treatment.

“These data clearly represent a substantial societal health gain and it can be concluded from our findings that, with some assumptions as defined in the model, use of CT-P10 will present significant savings for healthcare systems, in accordance with our stated hypothesis,” the study authors wrote.

They noted that their estimates could be on the conservative side if the price of CT-P10 is substantially lower than expected; their models assumed the biosimilar price would be 30% less costly than branded rituximab, but industry experts have said the actual difference could be twice as great.

However, the study authors acknowledged that the cost savings represent just one of the many factors that influence the uptake of biosimilars, including perceptions of the new drugs among patients, payers, and prescribers. For instance, clinicians must feel confident that CT-P10 is just as safe and effective as the branded drug for both, treatment-naïve patients and those switching from the branded drug to the biosimilar.

Rituximab Biosimilar Estimated to Save €90 Million Annually in the EU

State legislators in Nebraska have unanimously approved a biosimilar substitution bill in the first round of debate and plan to advance it through the legislature after revisions.

, who introduced the bill, “LB 481 is a critical piece of legislation for Nebraska to provide guidance for clinicians and dispensers as biosimilar products pass through the FDA approval process.” It would amend the Nebraska Drug Product Selection Act to allow pharmacists to substitute interchangeable biosimilar products in place of branded drugs.

Similar to the biosimilar substitution laws enacted in 28 other states, the proposed addition to Nebraska’s law requires pharmacists to notify patients if they dispense a biosimilar and must notify the prescribing provider of the switch via electronic health records. The 

 specifies that providers can prevent biosimilar substitution by writing on the prescription that they do not wish the pharmacist to select another drug. Patients and their caregivers may also indicate they want the product written on the prescription with no substitutions, if desired.

To help consumers become more educated about biosimilars, LB 481 also includes a requirement that Nebraska’s Department of Health and Human Services website must publish and update a list of all biological products deemed interchangeable by the FDA.

“Transparent communication between the patient, physician, and pharmacist is the hallmark of high quality patient care,” said Kuehn on his website. “Proactively establishing the communication framework for use of interchangeable biologics is a common sense step for promoting patient understanding of their own health care and communication among all members of the health care team.”

 about the proposed legislation included an account from Jackie Newman, whose young daughter has juvenile rheumatoid arthritis (RA). According to Newman, her daughter Zoe struggled with her painful condition before trying a biosimilar drug, which “relieved much of Zoe’s pain and drastically improved her quality of life.”

Newman now hopes that LB 481 will expand access to biosimilars for other patients and families seeking relief. The bill’s passage, she said, “will dramatically affect not only children like Zoe, but also the thousands of Nebraska patients who stand to benefit from the innovative new treatments biosimilars have to offer.”

The proposed legislation has also received support from the Coalition of State Rheumatology Organizations (CSRO), as some biosimilars are used to treat conditions like RA. The group said 

 that the bill “provides important pathways for access to these unique medications” while ensuring they are used with proper supervision. “CSRO supports the safe introduction of interchangeable biologic drugs into the practice of medicine in Nebraska and urges the passage of LB 481,” it concluded.

The bill was designated a priority by Jim Scheer, the Speaker of the Nebraska legislature. It is currently in the Enrollment & Review stage of the legislative process and will next move to the Final Reading, where a majority vote will determine whether it will proceed to Governor Pete Ricketts to be signed.

For more information on state biosimilar substitution laws as of March 2017, 

Nebraska Legislature Debates Biosimilar Substitution Bill

When biosimilar growth hormones were approved in England in 2008, onlookers predicted that the lower cost of the new medicines would drive prescribers to choose them over branded biological drugs. A 

, however, indicates that prescribing decisions are more commonly made on the basis of ease of use, not cost.

As of 2014, the biosimilar share of the growth hormone market was only 5% in England, while in countries like Poland they had a 99% market share due to reimbursement policies that required switching to the less expensive drugs. A group of researchers from Keele University in the United Kingdom set out to determine the trends in prescription of human growth hormone in primary and secondary care settings in England, as well as the causes of these trends. Their hypothesis, they wrote, was that “price would be the dominant influencing factor in the use of these medicines.”

Using data from the National Health Service from 2011 to 2015, the researchers analyzed prescribing trends of 12 preparations of growth hormone in primary and secondary care. Half of these came ready-to-use, while the other half required reconstitution before using. In primary care, they found that prices of the biosimilar growth hormones decreased by 15% over this time, while branded growth hormone prices remained steady, except for 1 product that saw its price decrease by 25%. They observed greater price reductions for more of the agents in secondary care.

Over the study period, growth hormone prescriptions declined by an average 0.45% per quarter in primary care, but increased by an average of 5.8% per quarter in secondary care. By the fourth quarter of 2015, 1 of the 2 biosimilar growth hormones accounted for 11% of the market.

In both primary and secondary care, statistical analyses did not find strong correlations between price per dose and usage for any of the products, although, for the biosimilar drugs, there were slight negative associations. Instead, the use of 5 out of 6 ready-to-use agents in primary care and all 6 in secondary care increased significantly over the study period, regardless of price. As both biosimilar products were ready-to-use, this pattern can account for some of the market growth of biosimilars. There were mostly decreases in the use of agents requiring more preparation in both care settings, although their prices had gone down.

According to the study authors, these factors suggest that “ease of use rather than price is the key driver for growth hormone product selection in primary and secondary care.” They noted that prescribing guidelines in England recommend that providers discuss the benefits and disadvantages of each product with their patients and respect the patients’ choice.

Previous studies of branded growth hormones have found that patients value ease of use and convenience. In addition to being quicker and easier to use, the ready-to-use drugs require smaller amounts of drug injected and have added buffers in the solution, which decreases the pain at the injection site.

This study confirms that patient opinions are affecting providers’ prescribing choices, as prescribers “take more account of patient preferences than central guidance on cost efficiency,” even if they adhere to the guidelines that attempt to control drug costs.

“This contrasts with other health economies, where mandated switching to growth hormone biosimilar meant that 99% of prescribing was the less expensive biosimilar,” the researchers concluded.

Prescribers in England Turn to Biosimilar Growth Hormones for Ease of Use, Not Cost

Britain’s departure from the European Union (EU) will necessitate a vast amount of changes, including a new location for the European Medicines Agency (EMA). Its leader worries that the move could slow down the drug approval pipeline.

Last week, Britain formally announced its intention to withdraw from the EU in a move commonly called “Brexit.” It will now have to sever ties from numerous European agencies within the 2-year transition window, including the EMA. Since the drug regulatory body’s inception 22 years ago, it has been located in London, but it will now have to find a new home by March 2019.

, Guido Rasi, the EMA’s executive director, voiced concerns that moving the agency could throw a wrench in its operations, which ensure the safety of the medicines taken by the 743 million residents of the EU. He is particularly worried that the European Council would drag its feet in determining the future home of the agency and its 900 staff. Italy, Denmark, Sweden, Spain, France, Ireland, and Poland have all expressed interest in becoming the EMA’s final destination. The decision could be made as early as this June, and Rasi expressed his view that a quick transition period is essential to getting the agency’s work back on track. 

Complicating the issue is the depleted work force of the EMA, as Reuters reports it is having a hard time recruiting replacements for several key staff who have left the agency. It normally receives around 2000 applications for its training program, but this year has only gotten 700.

The EMA already has a significant amount of work on its plate, including in the field of biosimilar review and approval, as it now prepares for the upheaval of moving. In March, for instance, 

 that it had filed for European approval of its trastuzumab biosimilar used to treat breast cancer, joining 3 other trastuzumab biosimilar applications in the agency’s queue. According to 

, it was in the process of evaluating 37 proposed biosimilars or non-orphan generics as of February.

A second question associated with the move will be that of redistributing the drug application reviews among 27 other countries, after Britain pulls out. Britain is expected to face the most impact, as the other countries currently contribute 80% of the work. Rasi suggested that EU and British leaders may forge an agreement that allows for mutual recognition of drug approvals in an effort to alleviate the burden to both sides. This deal could include components like the one 

 between the US and the EU, which indicated that the regulatory bodies will mutually recognize one another’s pharmaceutical manufacturing inspections.