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October 2016

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GLOBAL: Global pharmaceutical regulators forum proposes principles for indication extrapolation for biosimilars   +

The International Pharmaceutical Regulators Forum (IPRF) Biosimilars Working Group (BWG)* has released a reflection paper outlining principles that regulators around the world can use for extrapolating indication(s) during the authorization process for new biosimilars. They state that, in the context of biosimilars, the majority of national regulatory agencies (NRAs) agree that extrapolation of indication(s) can be granted on the basis of “totality-of-evidence”.** However, there appears to be no clear consensus on exactly which data should be submitted and how a decision to approve the extrapolation of indication(s) based on those data should be reached. Furthermore, the decision that is reached can differ between NRAs for scientific, legal or regulatory reasons, which may result in additional work for biosimilar developers.

*The IPRF is an international organization based in Switzerland. Their Biosimilars Working Group (BWG) was formed in February 2014 with 32 members from ten countries and three international organizations. The purpose of the working group is to discuss and harmonize the issues and challenges in terms of regulation of biosimilars among IPRF member countries.

**An approach advocated by the US Food and Drug Administration (FDA) and other NRAs, in which regulators consider the totality of the data and information, including structural and functional characterization, nonclinical evaluation, human pharmacokinetic/pharmacodynamic data, and clinical data, including immunogenicity.

Related article> (The reflection paper can be downloaded from this site)

GLOBAL: Call for clinical trials of biosimilars “to become more similar”   +

A second story regarding international harmonization: leading rheumatologists Jonathan Kay (USA) and John Isaacs (UK) have published a proposal in the official European League Against Rheumatism (EULAR) journal Annals of the Rheumatic Diseases for biosimilar trial design to be internationally standardized. They say that this standardization could be agreed upon and overseen by regulatory agencies around the world, and that introduction of consistency across clinical trials should increase confidence in biosimilars, both within the healthcare community and among patients. Elements to be standardized could include eligibility criteria, primary and secondary endpoints, assays used for pharmacokinetic and immunogenicity assessments, and statistical methodology.

 Related article>

EUROPE: NICE guidance on biologics will no longer differentiate between originators and biosimilars   +

The UK’s NICE (National Institute for Health and Care Excellence) has announced that, going forwards, all relevant published guidance that applies to an originator biological molecule will also apply to any licensed biosimilars. All existing guidance on biologics, for which at least one biosimilar is available on the UK market, will be amended to inform stakeholders and the public that the recommendations for the originator molecule also apply to any current and future biosimilar. Recommendations will refer to the INN (international non-proprietary name) and will not differentiate between the originator and biosimilar products. The guidance will also state that treatment should be initiated with the cheapest available product.

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EUROPE: French survey of patients with inflammatory bowel disease reveals limited understanding of biosimilars   +

A team of researchers in France, who surveyed 1,181 patients with inflammatory bowel disease, found that only 38% of respondents had heard of biosimilars, despite the fact that their condition is increasingly treated with biosimilars across Europe. When researchers asked these 383 people further questions to see what they knew about biosimilars, 47% said they were worried about safety and 40% claimed they were worried about efficacy. Only about 25% of those who were familiar with biosimilars said they didn’t have any concerns, the study found.

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UNITED STATES: FDA approves Erelzi™, a biosimilar of etanercept   +

The U.S. Food and Drug Administration (FDA) has approved ErelziTM (etanercept-szzs) for all indications included in the label of the originator product Enbrel®, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. Erelzi is the second biosimilar from Sandoz approved in the US through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. The FDA approval follows a unanimous vote (200) by the FDA's Arthritis Advisory Committee in July to recommend use of Erelzi for all of Enbrel’s indications.

Related article>

UNITED STATES: Court says Pfizer's infliximab biosimilar doesn't infringe Remicade® patent   +

Pfizer Inc.’s biosimilar of Johnson & Johnson’s TNF-alpha inhibitor Remicade® doesn’t infringe a patent, a federal court ruled last month, potentially clearing the way for the launch of the infliximab biosimilar onto the US market in October. Johnson & Johnson said it would appeal the decision and affirmed its sales projections.

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UNITED STATES: Names for interchangeable biosimilars may affect pharmacist dispensing habits   +

Nearly 63% of US pharmacists say they would feel more confident dispensing an interchangeable biosimilar if it shares the same INN (international non-proprietary name) as the brand-name biologic. The survey, which included 781 members of the Academy of Managed Care Pharmacy and the Hematology/Oncology Pharmacy Association, has just been published but was carried out last year. Since then, the FDA has released draft guidelines proposing that originator biologics and their biosimilars should share INNs, but that each should have a unique four-letter suffix. The survey points out that nearly half of the pharmacists preferred the approach that was eventually suggested by the FDA. Whether the agency ultimately adopts its own proposal remains to be seen.

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CANADA: Canada approves etanercept subsequent entry biologic (SEB)   +

Canada has approved BrenzysTM, its first SEB* version of Amgen’s Enbrel® (etanercept) made by Korean drugmaker Samsung Bioepis. The announcement was made just 2 weeks after the US approved its first etanercept biosimilar, Sandoz’ ErelziTM.

*A SEB (subsequent entry biologic) is the Canadian term for a biosimilar.

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ASIA PACIFIC: Australia's biosimilar substitution policy comes under fire as etanercept biosimilar is "A"-flagged   +

Australia’s Pharmaceutical Benefits Scheme Committee has announced that it intends to mark the originator and biosimilar versions of etanercept as equivalent in the Schedule of Pharmaceutical Benefits. This "A"-flagging means that, at the point of dispensing, pharmacists are free to opt for either product in all licensed indications that apply to both. The move has attracted criticism from prescribers and other stakeholders who feel that the prescribing clinician should retain control. However, the decision is in line with the stance Australia has maintained for some time regarding biosimilar substitution.

Related articles 1> 2> (subscription required)

ASIA PACIFIC: India announces new biosimilar guidelines   +

Revised guidelines for biosimilar manufacturers have been launched in India, to replace the original 2012 version. The new biosimilars policy, called the “Guidelines on Similar Biologics” was prepared by the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT). Key changes include: 

  • Clarification on the source of the reference product: if the reference product (originator biologic) is not marketed in India, it can be licensed in any ICH* country (i.e. EU, Japan, US, Canada, and Switzerland).
  • Provision for post-marketing studies: specific post-marketing safety data are required within 2 years of licensing through a pre-defined single arm study (n>200) and should be compared with historical data of the reference product. If immunogenicity is evaluated in clinical studies, it is not mandatory to carry out additional non-comparative immunogenicity assessments in post-marketing studies.
  • Option for waiver of safety and efficacy study: if a product demonstrates biosimilarity in terms of structural and functional properties, in vitro characterization, and pharmacokinetic/pharmacodynamic (PK/PD) markers that are surrogates of efficacy, Phase III clinical trials may be waived and replaced if necessary by an appropriate single-arm study (n≥100) in the most sensitive indication. Wherever the Phase III trial is waived, immunogenicity data should have been gathered in the PK/PD study and will also need to be generated during post-marketing studies.

*International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

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