Understanding biosimilars and legislative interchangeability designation is a growing concern for payers, manufacturers, prescribers, pharmacies, and patients, according to session speakers at AMCP 2023. Presenters addressed the regulatory landscape of biosimilars in the United States and outlined the evolving role of interchangeability. 

Regulatory Landscape 

Interchangeability refers to when biological products that meet federally mandated criteria are deemed an acceptable alternative to a reference product. The biological product must be biosimilar to the reference product, and using the biological product instead of the reference product should not cause any safety risks or decrease its efficacy, explained Adam Colburn, JD Director, government relations AMCP. 

While a federal definition of interchangeability exists, regulations can differ from state to state. Some states base their biosimilar substitutions based on drugs listed as therapeutically equivalent in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (referred to as the Orange or Purple Book); other states maintain their own lists. 

The speakers used states such as California, New York, and Hawaii as examples of diverse regulatory practice approaches concerning biosimilars. In California, the FDA's standards according to Section 262(k)(4) of Title 42 of the United States Code should be met for interchangeability, or equivalence should be established in the Purple Book. 

In New York, in addition to the prior requirements, interchangeability requires FDA licensing. Hawaii is the only state to not accept the federal definition of interchangeability for biosimilars and instead relies on director approval to be included on a state list of generic drug products and interchangeables. 

In some cases, pharmacists may use their discretion when deciding to switch a patient to an interchangeable biosimilar. However, in most states, the patient must be notified of the change at the point of sale and the prescriber must be informed within 3 to 5 days. Certain states may require the prescriber's approval before substitution, while others adhere to the "dispense as written" law.

The presenters highlighted cost as a crucial factor in the conversation around biologics. Substitution can sometimes be required if a biosimilar is a lower cost than the reference. Some states prohibit substitution for a Medicaid recipient if the state agency determines that a prescribed biologic is lower in net cost after rebates or pharmacists may be required to explain to patients the cost comparison of a biologic and a biosimilar.  

Notice and consent policies also differ between states. For the prescriber, many states allow them to prevent substitution. States may be required to send notice of substitution to a prescriber within a set time, other states consider updating electronic records accessible by the prescriber as adequate notice. For patients, they may receive notice of substitution, but other states only require the patient’s prior consent. The same variation by region holds true for substation practices. 

“Legal immunity is broadly unclear at a legislative level,” said Mr Colburn. 

Immunity is currently available in select states for pharmacists as long as their substitution complies with state law or applies the same liability standards as for prescribing generics. 

Practical Considerations

“Since 2015, biosimilars have generated more than $13 billion dollars in health care savings,” said Gary Rice, RPh, MS, MBA, CSP, senior advisor, MedImpact Healthcare System, Inc. “The latest projections suggest that savings could exceed $180 million dollars in the next 5 years.” 

Despite the significant cost and care implications of biologics from a managed care perspective, Medicare generally encourages the use of biosimilars but still has been slow to prioritize biosimilars over reference biologics. Medicaid-preferred drug lists vary from state to state, but the Centers for Medicare & Medicaid Services (CMS) encourages states to include biosimilars. Commercial payers could prioritize biosimilars in formulary placement or could cover both the reference and the biosimilar.

Mr Rice emphasized that while biosimilars may be a relatively new pharmaceutical development, many therapies such as human growth hormones, insulin, and influenza vaccines have faced similar concerns to biosimilars. He also highlighted that understanding and embracing biosimilars has never been more relevant as many have already been launched in the United States to date and in 2023, multiple adalimumab biosimilars will enter the market. The first adalimumab biosimilar, adalimumab-atto (Amjevita), was already approved in January 2023.

Seven key considerations for evaluating biosimilars were shared and are as follows: 

• clinical efficacy;
• toxicity and immunogenicity;
• supplier manufacturer capability;
• supplier reliability;
• cost savings to payer;
• dosage form for target population; and
• patient adherence. 

“Price will also be a significant guiding force,” said Mr Rice. 

It is yet unknown what influence biosimilar interchangeability will have on payer formulary coverage, provider prescribing and patient acceptance for biosimilars. 

“Because interchangeability designation is unique to the United States, we do not have any historical perspective,” said Mr Rice. “We do not have the luxury of looking to see what the experience of other countries has been with biosimilars.” 

Biosimilar Influencers 

While many details of the future of biosimilars remain to be seen, the speakers charged the audience to consider their own influence. 

“The payer, manufacturer, prescriber, pharmacy, and patient will be the key influencers when it comes to acceptance and utilization of biosimilars,” said Mr Rice.

Payers can increase competition as the market fills with options and optimize the opportunity for lower costs and generate additional savings. 

Pharmacies, regardless of the distribution model, can influence a prescriber's decision. Pharmacies can also assist with prior authorization, provide patient funding help and training, as well as utilize digital and fax communication tools to initiate contact with a prescriber. All these factors are crucial in determining a patient's health care plans and outcomes.

“Manufacturers have to work on developing trust in their biosimilars. They must educate patients and prescribers and demonstrate safety, efficacy, and viability,” said Mr Rice. “At the end of the day if the prescriber is not comfortable with the product, they will not prescribe it. If the patient is not comfortable with the product, they will not get it filled.”  

The presenters emphasized existing research identifies the main hurdles to biosimilar adoption include education/awareness, a streamlined prescriber process, and financial incentives for patients and prescribers. 

“The three Es of biosimilars are educate, educate, and educate,” said Mr Rice. 

It is important to understand the complexities of substitution laws concerning biosimilars, and all influencers in the health care ecosystem should be involved in the optimization of biosimilar use. More guidance and regulations are on the way, and the health care system will all be faced with a learning curve as this developing technology continues to gain prominence. 

“There needs to be an overall collaborative effort so that we all are aligned,” said Mr Rice.