Biosimilars in the United States: Current Status and Future Implications

Biosimilars in the United States: Current Status and Future Implications

September 28, 2017
3 min read

WHO creates pilot program to use biosimilars to address ‘prohibitively expensive’ cancer drugs

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The WHO has launched a pilot project to encourage the development of biosimilar versions of rituximab and trastuzumab – two products on the WHO Essential Medicines List – to help increase competition and make expensive cancer treatments more widely available in low- and middle-income countries.

“Biotherapeutic products have shown added value in terms of treating many diseases, particularly cancers and other non-communicable conditions,” Emer Cooke, head of regulation of medicines and other health technologies at WHO, told HemOnc Today. “But they are prohibitively expensive and out of reach of numerous countries. ‘Similars’ of these products are cheaper, but we must ensure that they are good quality, safe and effective. The aim therefore, is to increase the number of affordable quality biotherapeutics for international procurement.”

WHO is inviting manufacturers to submit biosimilar versions of the cancer treatments for assessment, and if the products are found to meet international standards for quality, safety and efficacy, the organization will ‘prequalify’ them, Cooke said.

A prequalification gives countries with weak regulation the assurance needed when making the decision to purchase medical products. The UN and other international procurers, such as the Global Fund, tend to rely on a WHO prequalification when buying products in bulk.

“It’s like an international quality assurance service,” Cooke said. “Companies that receive prequalification for certain products have a much better chance to win international tenders.”

Manufacturers can either submit applications with products that have already received approval by either stringent or non-stringent regulatory authorities

Cooke told HemOnc Today the WHO chose rituximab (Rituxan; Genentech, Biogen) and trastuzumab (Herceptin, Genentech) as the first test cases because the two are considered “fundamental for all health systems.”

The inclusion of rituximab and trastuzumab on the WHO Essential Medicines List triggered requests to the Essential Medicines and Healthcare Products Department from United Nations procurement agencies and WHO disease programs to help facilitate access to quality versions of biosimilar products at affordable prices, according to information posted on the WHO website.

“The more quality generics on the market, the more prices come down,” Cooke said about increasing competition.

Cooke also added that the WHO may extend the pilot project to include biotherapeutics for insulin, “as diabetes has become a major concern in the developing world.”

If the organization determines that the biosimilars submitted for prequalification are comparable to originator products in terms of quality, safety and efficacy, the medicines will be listed by WHO and become eligible for procurement by United Nations agencies, according to its website.

“We would like to stress that quality, safety and efficacy are extremely important, so both manufacturers and regulators must take care when transitioning to biosimilars or introducing them in their treatment guidelines,” Cooke said. “The other issue is that patients are still skeptical towards these products, much like they were skeptical 10 years ago with respect to generic medicines. So, we will need to educate the public and health workers.”

The pilot project is an effort to realize the promise of biosimilars, according to Robert M. Rifkin, MD, FACP, medical director for biosimilars with McKesson Specialty Health and US Oncology Network.

“It's a mechanism to help get the drugs out there, but the thing the WHO would not want to do - nor would any of us want to do - is to compromise safety,” Rifkin told HemOnc Today.

Rifkin added that the plan with the project is to provide clear guidance to the manufacturers that want to apply for prequalification of their biotherapeutics.

“In order for things to prequalify, there have to be rules,” he said. “So, the WHO is creating this pilot project. And there will still be stringent regulatory approvals, so they don't intend to let safety lapse. These documents for the two molecules will hopefully be available in October.” – by Ryan McDonald


Disclosure: Cooke and Rifkin report no relevant financial disclosures.