Biosimilar Prequalification Program in Development

The World Health Organization (WHO) recently announced plans to launch a pilot program for prequalifying biosimilars. This new program would be a step toward making expensive biologic drugs, including those that treat cancer, more widely available for use in lower-income countries, according to a press release.

In September, the WHO will request that manufacturers apply for prequalification for biosimilars of rituximab and trastuzumab, which are both on the WHO Essential Medicines List. Rituximab (Rituxan) is indicated to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, and trastuzumab is indicated to treat breast cancer.

The decision to develop the novel program was the result of a meeting between the WHO, national regulators, pharmaceutical industry groups, patient and civil society groups, payers, and policymakers, who gathered to discuss increasing access to biologic drugs, according to the release.

The WHO also has future plans to explore ways to prequalify insulin, since it has become increasingly costly.

Biologic drugs have become a novel and effective way to treat diseases, including cancers and autoimmune disorders. Much like generic drugs, biosimilars can be a less costly alternative to a reference product.

Biosimilars are typically manufactured after the reference product’s patent has expired, which removes legal barriers. Since many patents are expiring, more biosimilars are emerging. To date, there have been 6 biosimilars approved.

The WHO reported that biosimilars could increase access to effective treatment in lower-income countries and has the potential to reduce healthcare costs in high-income countries.

“Innovator biotherapeutic products are often too expensive for many countries, so biosimilars are a good opportunity to expand access and support countries to regulate and use these medicines,” said Marie-Paule Kieny, WHO assistant director general for Health Systems and Innovation.

During investigation, if the WHO finds that submitted biosimilars are comparable to the reference product, the drugs will be listed by the organization and become eligible for procurement by United Nations agencies, according to the release.

Currently, many lower income countries rely on WHO prequalification before buying drugs. Prequalification could also be used to increase competition in the industry and drive down costs.

The WHO also plans to review its 2009 guidelines related to the evaluation of similar biologic drugs to ensure that it includes more recent findings, according to the release.

“Biosimilars could be game-changers for access to medicines for certain complex conditions,” said Suzanne Hill, WHO director of Essential Medicines and Health Products. “But they need to be regulated appropriately to ensure therapeutic value and patient safety.”

The uptake of biosimilars also requires the participation of patients and physicians, who must understand that the benefits outweigh the risks for biosimilars, the WHO reported.

Additionally, the WHO will seek out testimony from countries who have had positive experiences with biosimilars, as well as partnering with organizations to educate prescribers and patients about biosimilars.

The WHO has announced plans to advocate fair biologic drug prices to ensure that patients and the public can benefit from the drugs. This initiative includes supporting countries in creating price-setting strategies that will lead to sustainable markets to deliver healthcare to patients, savings to payers, and incentives to manufacturers to ensure the drugs are continuing to be produced, the release concluded.