Convincing data to support the safety and effectiveness is key.
The biopharma industry has the opportunity to change lives--and possibly the world--with the creation of biosimilars. Patients get more treatment options, with more access to global medicines and new revenue streams to the marketing authorization holders (MAHs) who bring products to market.
With many patents of branded biologics expiring, the biosimilars industry holds incredible growth potential, with a September 2015 report predicting revenues from such products will grow to $26.5 billion by 2020, up from $2.5 billion in 2014. While biosimilars are approved as highly similar versions of already authorized biologics, MAHs will have to convince regulators, payers, physicians and patients that they are as safe and effective as their originators when used in the real-world.
To convince these various stakeholders, MAHs will need to generate comprehensive and convincing data to support the safety and effectiveness of their products. A key component of that process is the evaluation of real-world evidence to augment data generated by the analytical studies, animal studies and clinical studies that can fill the evidence gap for decision-makers. Real-world evidence generation strategies should be part of the post-approval plan from the outset with early planning taking into account how to accommodate the unique interests of all relevant stakeholders.
Once regulatory approval is obtained, regulatory agencies are mainly concerned about safety issues, including delayed risks, while clinicians and patients have interests in both clinical effectiveness and safety, as well as how the risks and benefits of one treatment compare with another, particularly for patients who switch from the originator biologic.
Payers’ interests will be similar to physicians and patients, but they will consider these issues through the lens of economic risk-benefit considerations and how use of the biosimilar impacts related medical care.
MAHs may also want to consider how the interests of these stakeholders vary across different markets. For example, while the National Health Service in the U.K. provides coverage from "cradle to grave," in the US, the average duration of coverage by private health insurance for an adult member under age 65 is about 2.5 years, thus delayed risks and benefits may be less important to stakeholders in those markets that do not provide lifetime coverage, according to Quintiles.
Economic considerations are also important to patients and healthcare providers, since in some countries, including China and India, patients directly bear the costs of pharmacotherapy. These economic considerations must be balanced with benefits achieved in broader population access to these life-altering treatments. Crafting an evidence generation strategy targeting the needs of all of these varied players will help MAHs assemble a more convincing body of high-quality data to support the real-world safety and effectiveness of their products.