Sandoz unveils global action plan to improve access to biosimilars

As the spotlight trains on access to biosimilars, Novartis’ generics unit on Thursday released a global action plan to boost biosimilar adoption by 2030.

The action plan is part of the Act4Biosimilars initiative launched by Sandoz last year and led by a steering committee of patient advocates, healthcare professionals and other experts. The plan includes recommendations for streamlining the regulatory process, driving patient awareness and fighting misinformation.

The overall goal? To improve biosimilar adoption by at least 30 percentage points in 30 target countries by the end of the decade, Sandoz announced Thursday. As part of the initiative, Act4Biosimilars is also releasing a series of regional reports on biosimilar access, starting with the Americas.

In the US, the report noted that interchangeability designations — governing whether a brand-name drug can be substituted for certain biosimilars at the pharmacy without a doctor’s intervention — as a source of confusion among patients and healthcare professionals.

“That has given the impression that there are two quality levels of biosimilars, which is nonsense,” said steering committee member Arnold Vulto, who founded the consulting firm Vulto Pharma Education & Consultancy. “It’s just a regulatory hurdle.”

The steering committee will also release reports on Europe, the Middle East and Africa and Asia Pacific in the coming months.

The news comes days after the FDA and International Pharmaceutical Regulators Program’s Biosimilars Working Group announced a workshop to take place in September reevaluating the need for comparative clinical efficacy studies. Comparative studies are conducted to ensure that there are no clinically meaningful differences in safety of efficacy between a proposed biosimilar and its reference product. However, some have argued that the trials are unnecessary and costly. Clinical efficacy studies often account for more than 70% of the cost of developing a biosimilar, according to a 2022 paper by University of Illinois adjunct professor Sarfaraz Niazi.

“Testing drugs in patients is the gold standard for developing new drugs,” Niazi writes. “But for drugs whose efficacy and safety have already well-established, such testing is redundant as long as the products are similar at the molecular level.”

Biosimilars are expected to generate $290 billion in global savings between now and 2027, Sandoz reported on Thursday.

“If the development process could be streamlined and become less costly … that would be a tremendous reduction in cost in the benefit of patients,” Vulto said, adding that there’s a need to improve education for patients and healthcare professionals on biosimilars. “We have to see it as a societal responsibility.”

Claire D’Abreu-Hayling

Sandoz CSO Claire D’Abreu-Hayling said in an email to Endpoints News that a key challenge to the adoption of biosimilars is a “lack of acceptability” among healthcare professionals and patients.

“This can be caused by many things, including disinformation campaigns, a lack of consistent information or a lack of information all together. This is why Act4Biosimilars promotes the publication of authoritative local educational content and the exchange of information and experiences between HCPs and patient advocates,” she said.

Novartis announced plans last year to spin off Sandoz. The separation is expected to be completed in the second half of this year, the company said earlier this month.

biosimilars
generics
pharma
healthcare
fda