Who We Are

The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.

Our Perspective

Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars  On March 11th, the Biden Administration released its FY25 HHS Budget. In response, ASBM Executive Director Michael Reilly published a blog post sharing his concerns with the Administration’s proposal to permit widespread automatic (pharmacy-level) substitution of all biosimilars in place of their reference products; without physician approval or FDA evaluation as current law requires. From the post: The HHS Budget in Brief document describes the policy objective simply enough: “Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.  It justifies the policy by claiming “this change makes the U.S. biosimilar program more consistent with the approach adopted by other major regulatory jurisdictions such as the European Union where biosimilars are interchangeable with their respective reference products upon approval.”  In the U.S. and Europe alike, prescribers can already substitute any biosimilar for its reference product. What is at stake and where the two regions differ somewhat in policy is when and how pharmacies can substitute biosimilars. The confusion stems from the fact that the term “interchangeable” has different meanings in the U.S. and Europe:  In Europe,“Interchangeable” means prescriber-substitutable: The European Medicines Agency (EMA) has stated all biosimilars it approves are “interchangeable” in that they “may be prescribed interchangeably” and that this does not refer to pharmacy substitution: “Member States will continue to decide…whether automatic substitution is allowed at the pharmacy level.” In the U.S., however, “interchangeable” refers to a biosimilar which under state law may be substituted at the pharmacy level without physician approval because its manufacturer has provided additional data to the FDA demonstrating a patient can be switched between the biosimilar and reference product and expect the same result. Currently there are 10 biosimilars that can be substituted by U.S. pharmacies in this manner, with more on the way. 69% of US physicians surveyed consider it “very important or critical” that patients and physicians decide the most suitable biologic to use- be it the reference product or one of the biosimilars to that product. However 59% of physicians are more comfortable with an interchangeable being substituted in place of the prescribed originator product.  The Biden budget proposal would undermine this hard-won confidence by eliminating the FDA’s science-based data requirements for permitting pharmacy-substitution of biosimilars, and declaring by fiat that all biosimilars substitutable by the pharmacy, despite the opposition from U.S. physicians. And it does so based at least in part on a serious misunderstanding of what the health systems of other advanced countries permit.  Read more here.  View ASBM’s educational fact sheet “Interchangeability: US vs EU” here.

Biden’s SOTU: 500 Drugs To Be Subject to Medicare Drug Price Controls  On March 7th, President Biden gave his State of the Union address to Congress, wherein he laid out upcoming policy priorities for a potential second term. Among these was an expansion of the Medicare Drug price setting provisions passed in 2022 as part of the Inflation Reduction Act (IRA). Biden seeks to dramatically increase the number of drugs subject to Medicare price negotiations, said President Biden in the address:This year Medicare is negotiating lower prices for some of the costliest drugs on the market that treat everything from heart disease to arthritis. Now it’s time to go further and give Medicare the power to negotiate lower prices for 500 drugs over the next decade. CMS is currently working to set prices for 10 drugs, with the final prices set to be announced by Sept. 1 and go into effect in 2026. Without a change, the number of eligible drugs will increase to 15 in 2027 and 2028 and to 20 every year thereafter. ASBM recently hosted a webinar in which former government health officials who worked on Medicare Part D, the program’s prescription drug benefit, discuss the harmful impacts of the IRA’s price setting policies.   Read more about how IRA Medicare Drug price setting will negatively affect patient access to new medicines at ASBM’s microsite IRAPatientInfo.org.

ASBM Presents at World Health Organization’s 78th INN Consultation  On March 19th, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 78th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland on October 18th, 2023. ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. The proceedings of the INN Consultation are bound by confidentiality pending the publication of the Executive Summary by the WHO. However, the recently-released Executive Summary from the 77th INN Consulation (held October 19, 2023) lays out the benefits for a distinct nomenclature standard, and highlights the ongoing support for such a standard, both from ASBM as well as from regulators. From the Executive Summary: The ASBM has supported the INN Group’s Biological Qualifier (BQ) scheme since its inception in 2012, and since then has doggedly presented data on the importance of a BQ to enhancing patient safety and pharmacovigilance (PV). However, they have also learned that WHO moves slowly, has many global health issues to deal with and has many stakeholders. Almost 10 years after the inception of the BQ, with no further action ensuing, a WHO report in 2021 highlighted that a lack of consistency in naming biosimilars had caused concern in prescribing, prescription mix-ups, unintended switching and traceability, and concluded that naming and labelling was important for product identification, PV and prescribing. When the BQ was first proposed, ASBM noted that several global regulatory agencies supported the scheme, including the US FDA which eventually adopted its own not dissimilar system comprising a random four-letter suffix. Other supporting agencies await the WHO implementing a global system. In the EU, the EMA has stated that it does not need a BQ as it has an alternative system in place but recognises the value of a unified system. Several arguments have been raised by stakeholders opposed to a BQ; however, in each case these have proven to be unfounded. For example, it had been stated that distinguishable names may imply inferior products, but this has not been the case in USA. In addition, surveys have shown that a supposed lack of support by physicians and global regulators was incorrect.  Over these years also, the ASBM has surveyed and met with many global regulators and physicians and the vast majority support distinct nomenclature. The lack of action with the BQ has forced many regulators, either assigning the same non-proprietary name to biosimilars or in some cases to adopt their own system. However, most of them are willing to support a WHO system if it is implemented. The ASBM made a proposal to quantify support for the BQ. . It acknowledged support for a BQ system and with the debate having continued for 10 years now it strongly encourage the WHO to take a leadership role.  Dr Balocco noted that the department had a new ADG and that WHO was soon to have a new Director-General. The WHO has been asked to work on a Global Substance Identifier (GSID) and there may be an opportunity to bring in the BQ as part of this. The INN Programme is in fact ready to implement a BQ. Dr Balocco expressed hope that a decision would be taken soon as the INN by itself is not sufficient for PV.   Read the full Executive Summary of the 77th INN Consultation here.

Reminder: EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development; Comments Due April 30   On January 25, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) released a document entitled “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development”.  The document expresses the EMA’s intent to streamline biosimilar development by re-evaluating the role of clinical safety and efficacy data; it also announces a three-month public consultation period running from February 1 to April 30, 2024. From the announcement: Constantly striving for scientifically sound yet efficient processes, the Biosimilar regulatory framework has constantly been evolving towards increasingly tailored developments, starting from smaller and “simpler” biologics, such as recombinant Granulocyte-Colony Stimulating Factor (rG-CSF), insulins or somatropin where the need for comparative clinical efficacy trials is in general not required any more. With growing knowledge and the increasing possibilities of analytical and functional characterisation, revisiting the need for clinical efficacy trials for biosimilars (especially recombinant proteins and mAbs) is considered the next important step in order to keep the Biosimilar pathway attractive for developers and, at the same time, guarantee future access to safe and efficacious biologics for European patients. The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. When the biosimilar demonstrates a high degree of similarity to the RMP at the analytical and functional level, it may be possible to justify the omission of dedicated CES. Comments may be submitted here until April 30, 2024. Read the concept paper here.

How IRA Price Setting Disccourages Biosimilar Development In a recent op-ed in USA Today, Rutgers University professor Sandip Shah, argues that the price-setting provisions of the Inflation Reduction Act (IRA) are unintentionally disincentivizing biosimilar development:The IRA permits Medicare officials to impose price controls on certain brand-name drugs, including many biologics. But the government does not have to reveal which medicines will be subject to price caps until just two years prior to the lower prices taking effect.As a result, a firm could hypothetically spend nearly a decade and hundreds of millions of dollars developing a biosimilar — only to find out that the original brand-name biologic will suddenly be much cheaper, courtesy of government price controls. In such a scenario, the biosimilar developer would be unable to gain enough market share to break even on its R&D investments, let alone earn a modest return.Lawmakers can restore incentives for biosimilar drug makers by automatically — and permanently — exempting from price controls any biologic for which there is a biosimilar competitor in development.Unless and until that happens, the legacy of the Inflation Reduction Act will be reduced access to low-cost biosimilars — ultimately leading to higher drug spending. Read the op-ed here.

FDA Approves Three Interchangeable Biosimilars in First Quarter of 2024  During the first quarter of 2024, the FDA approved three additional interchangeable biosimilars, bringing the total number of approved interchangeable biosimilars to 10, and the total number of biosimilars to 48.  On February 24th, the FDA approved Simlandi (adalimumab-ryvk), a biosimilar to Humira (adalimumab). The TNF alpha inhibitor was approved for treating plaque psoriasis, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, and uveitis. On March 5th the FDA approved two interchangeable biosimilars: Jubbonti (denosumab-bbdz), interchangeable for Prolia (denosumab), and Wyost (denosumab-bbdz), interchangeable for Xgeva (denosumab). Jubbonti was approved for increasing bone mass in men and women and breast cancer, for osteoporosis (induced by glucocorticoid treatment or otherwise) in men and women, and for preventing fracture in post-menopausal women with osteoporosis. Wyost was approved for treating patients with multiple myeloma and solid tumor bone metastases, giant cell bone tumors, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Read more about the approvals here and here.

Missed last month’s ASBM Newsletter?Read it here.