Industry News

December 2017

Learn about recent developments across the biosimilar industry. Visit our News Archive to find out more.

GLOBAL: Speculation about the “nocebo” effect with biosimilars increases   +

A new study published in Arthritis & Rheumatology reports that 24% of patients (n=192) who switched from Remicade® to an infliximab biosimilar (CT-P13) had discontinued treatment within 6 months primarily due to “subjective health complaints.” The authors attribute the CT-P13 discontinuation to a possible “nocebo” effect. Similar findings were obtained from a study of a nationwide switch from originator infliximab to a biosimilar in Denmark, in which the investigators reported that 16% of patients stopped treatment, even if disease activity seemed largely unaffected by the switch. The nocebo effect is a phenomenon that occurs when a patient’s negative expectation causes a treatment to perform less well than it otherwise would – essentially, the opposite of a placebo effect. The effect can be attributed to a patient’s perception that the biosimilar is inferior to the originator drug – a perception that may be inferred from comments made by prescribers about the need to prescribe a more affordable treatment. The way in which physicians communicate with patients about switching to a biosimilar is considered key to preventing the nocebo effect and helping to ensure the success of transitioning to biosimilars in daily practice.

Meanwhile, at the 2017 American College of Rheumatology’s (ACR) Annual Meeting in San Diego, CA, USA, four separate studies analyzed the reasons for successes and failures in non-medical switching initiatives (i.e. pharmacy-level substitution) concerning etanercept and infliximab biosimilars. Although non-medical switching has implications beyond switching that’s authorized by a prescriber, patient communication was again highlighted as a key driver of success or failure.

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GLOBAL: Boehringer Ingelheim’s adalimumab biosimilar shows promise after switching   +

Boehringer Ingelheim has announced 48-week data from a Phase 3 clinical trial comparing their adalimumab biosimilar Cyltezo® with Humira® in moderate-to-severe rheumatoid arthritis (RA). The data showed that Cyltezo® has no clinically meaningful differences in efficacy, safety, and immunogenicity to Humira®, even in patients who switched from Humira® to Cyltezo® at Week 24. Meanwhile – as it faces the prospect of oncoming biosimilar competition to Humira® – AbbVie is developing a new innovator product, which could help it retain a hold on the market. Results from three recent Phase 3 clinical trials show AbbVie’s investigational interleukin-23 (IL-23) inhibitor, risankizumab, to be more effective than adalimumab (Humira®) or ustekinumab (Stelara®) in patients with moderate-to-severe plaque psoriasis.

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GLOBAL: Global biosimilars market estimated to be worth over $13 billion by 2024   +

According to a new market research forecast from Hexa Research, the global biosimilars market is expected to reach $13.1 billion by 2024 as a result of a continued rise in the prevalence of cancer and chronic conditions, such as diabetes and autoimmune diseases.

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EUROPE: European Commission launches consultation on patent protection schemes and exemptions   +

The European Commission has launched a public consultation on supplementary protection certificates (SPCs) and related patent exemptions, which could have a significant impact on the biosimilars marketplace. SPCs are an intellectual property right that grants an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical. The goal of the SPC is to offset the loss of patent protection that occurs during the development and clinical trials of a generic product. Bolar patent exemptions, which are intended to speed market entry of generic and biosimilar therapies, provide exemptions to patent protection, even in cases where SPCs are in force. These exemptions state that some pre-market activities cannot be regarded as infringements of a patent or SPC. However, because SPCs are granted and enforced at a national level, rather than a European Union (EU) level, confusion about these certificates and their related Bolar exemptions is widespread. For example, in some EU member states, Bolar exemptions do not permit access to active pharmaceutical ingredients for the purpose of biosimilar development. Bolar exemptions have also been under scrutiny as they may prevent EU manufacturers from competing in non-EU markets during the SPC term. In addition, SPCs have been questioned in the biosimilars context due to the very nature of biosimilar therapies. Because SPCs cover the active ingredient in a product and because biosimilars are, by definition, only “highly similar” to their originators, there remains some question as to whether SPCs can be legitimately applied to forestall biosimilar development. The new consultation is intended to gain feedback from stakeholders in order to determine a future course of action by the European Commission.

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USA: CMS reverses its policy on biosimilar reimbursement   +

The Centers for Medicare & Medicaid Services (CMS) has announced a long-awaited change to its present policy on biosimilar reimbursement, stating that it will begin issuing unique Healthcare Common Procedure Coding System (HCPCS) codes (often referred to as “J-codes”) to each individual biosimilar product, beginning on or after January 1, 2018. Currently, Medicare Part B pays for biosimilars under the Physician Fee Schedule (PFS) based on the average sales price (ASP) of all biosimilar products within the same HCPCS code – grouping together all biosimilar products with the same reference product to calculate an ASP. This arrangement has meant that physicians are reimbursed the same amount for all biosimilars of the same reference product. The policy change is being welcomed warmly by many stakeholders including the Biosimilars Forum, professional bodies such as the American College of Rheumatology, and a number of patient organizations – who have all been actively campaigning for this amended policy to ensure a robust, competitive US biosimilars market. The coding change may also help reduce pharmacovigilance concerns among providers who are considering prescribing biosimilars.

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USA: New RAND Corporation forecast predicts savings from biosimilars of $54 billion in next 10 years   +

The widespread introduction of biosimilars could cut healthcare spending in the US by $54 billion over the next decade, according to a new analysis from the RAND Corporation. The savings estimate is about 20% higher than a similar analysis done by RAND researchers 3 years ago, representing both improved analysis methods and the rapid growth in spending on biologics overall. The report states a number of assumptions, which underpinned the prediction, and also acknowledges that the savings achieved will hinge on the evolving competitive landscape, on regulatory decisions, and on insurer efforts to promote biosimilar uptake through payment rates and other strategies. The authors further comment that it remains to be seen who will actually benefit from the savings.

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USA: FDA launches new biosimilars educational campaign for prescribers   +

The US Food and Drug Administration (FDA) has announced the launch of a new educational initiative on biosimilars “to help healthcare providers gain a better understanding of these important products and the approval process they undergo.” A major new section of the FDA’s website provides downloadable factsheets and infographics on biosimilars for prescribers, as well as materials for organizations to use in disseminating this information to interested parties. The available resources give basic definitions of key terminology, describe the rigorous standards any biosimilar must meet to gain approval (and how the FDA approval pathway works), and provide digestible information about the data and information the FDA reviews to determine biosimilarity. The new website also raises awareness about an important FDA reference source on biosimilars known as the Purple Book, and offers access to online presentations, courses, and webinars. The FDA plans to embark shortly on additional research with healthcare professionals to learn more about the types of information they need to effectively communicate about biosimilars with their patients.

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LATIN AMERICA: Conflict erupts in Columbia over plans for an abbreviated route to biosimilar approval   +

Colombia’s Health Ministry and the Columbian research and development-based pharmaceutical industry association, Afidro, are at loggerheads over proposed legislation that gives biosimilars a faster route to market. The legislation in question sets out a controversial “abbreviated comparability route,” which reduces the requirement for comparative data (except for immunogenicity testing) with the aim of expediting patient access to affordable biologic therapies. The legislation finally came into force in August 2017 after several setbacks, but may yet be stopped in its tracks. Some months previously, Afidro had filed a complaint with the Council of State (Colombia’s highest court, presiding over administrative issues) demanding that the decree be suspended because the super-abbreviated route to approval is “not safe and does not conform to international standards.” In September, the Council of State finally allowed Afidro’s application and officially notified the Health Ministry. In response, the Health Ministry has accused Afidro of self-serving commercial interests. It insists that because the active ingredients in the reference products are widely known, the abbreviated pathway – which still calls for immunogenicity testing and robust pharmacovigilance – is justified. The Ministry has asked the Council of State to consider ethical standards that, in line with the Declaration of Helsinki, require that experiments on humans “should not be repeated to demonstrate things that have already been demonstrated.” In a counter-statement, Afidro maintained that an approval pathway that allows an applicant to rely entirely on the data of a third party, without doing clinical comparative studies, is not acceptable.

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ASIA PACIFIC: Australian Medical Association criticizes the national government's approach to biosimilars   +

The Australian Medical Association (AMA) has raised concerns about the national government’s “heavy handed” new proposals for boosting biosimilar uptake in Australia. Firstly, as part of a software update to doctors’ prescribing systems, the government is planning to include an alert to prescribers stating that biosimilars are “preferred” for treatment-naïve patients. The AMA maintains that use of this alert across the board is misleading, because it is based only on cost-effectiveness and not on other potentially significant clinical considerations. Secondly, the government has proposed reducing the level of authorization required to prescribe a biosimilar, while maintaining the need for this authorization in the case of originators. Under the Australian system, some prescriptions covered under the nation’s Pharmaceutical Benefit Scheme (PBS) must be approved on a case-by-case basis, because they have been deemed too costly for widespread use. However, some medicines may be prescribed under a “streamlined” arrangement using a special authority code. The AMA has criticized the government’s proposed action of moving biosimilar etanercept to a streamlined approach, while keeping originator etanercept at the highest level of authorization, on the basis that it undermines prescribing freedom. It argues that the government’s biosimilar awareness program should be given time to work and that biosimilar uptake will proceed naturally as more products enter the market. The AMA also noted that biosimilar and reference etanercept are actually listed at the same price on the PBS and commented that: “unless a biosimilar product is listed on the PBS for a significantly lower price, there appears no justification for applying different restrictions to the same medicine on the basis of brand.”

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