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November 2016

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UNITED STATES: FDA approves Amgen’s biosimilar of Humira® (adalimumab)   +

The U.S. Food and Drug Administration (FDA) has approved Amgen’s biosimilar of AbbVie’s blockbuster Humira® (adalimumab) – the world’s first approval of an adalimumab biosimilar in a highly regulated market. The biosimilar, which has the trade name AmjevitaTM and the non-proprietary name adalimumab-atto, is the fourth biosimilar to be approved by the FDA.* Amjevita was approved for six of Humira’s ten indications; the patents for three other indications – pediatric Crohn's disease, hidradenitis suppurativa, and uveitis – are yet to expire. In addition, Amjevita was approved for juvenile idiopathic arthritis (JIA) in children who are 4 years of age or more; Humira still has a patent covering the treatment of children with JIA as young as 2 years of age. AbbVie has stated that it anticipated Amjevita would be approved, but has made no secret of its intention to retain market exclusivity until 2022. The company is currently involved in a number of court cases with Amgen about the validity of several of Humira’s patents. Lawsuits aside, the earliest Amgen will be able to launch its product is March 2017, due to the required 180-day notice period following FDA approval.

Industry commentators agree that the FDA’s approval of a Humira biosimilar (and its recent approval of a biosimilar of Enbrel®) will trigger an escalation in biosimilar applications. Currently, the FDA is advising companies developing approximately 60 candidate biosimilars based on more than 20 originator biologics. To date, FDA Advisory Committee meetings have been held for each of the biosimilars on a pathway to approval, but the FDA has announced that this will not be necessary in the case of subsequent biosimilars of the same originator.

*Like the other three FDA-approved biosimilars, Amjevita is not designated as "interchangeable" (i.e. able to be substituted for the originator by a pharmacist without prescriber consultation). The FDA’s criteria for an interchangeability licence are still awaited.

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UNITED STATES: Second major US payer drops originators for biosimilars   +

UnitedHealth has announced that ZarxioTM, a biosimilar of filgrastim, and BasaglarTM, a follow-on biologic* of insulin glargine, will replace their respective originator products, Neupogen® and Lantus®, on its formulary in 2017. The news follows a similar announcement made recently by CVS Health. Industry analyst Ronny Gal anticipated that similar payer decisions could well be forthcoming when other biosimilars arrive on the US market. He noted that, “We are seeing commercial payers making more aggressive steps to control formulary costs” but acknowledged that these changes are being made at a significantly faster rate than analysts had expected.

*Basaglar was not approved via the FDA’s dedicated biosimilars pathway 351(k) and is therefore referred to as a “follow-on biologic”.

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UNITED STATES: New QuintilesIMS report asks “Who will benefit from US biosimilar cost savings?”   +

A new white paper issued by QuintilesIMS has revealed that patients in the US may not individually benefit from lower priced biosimilars – it will chiefly be payers who benefit. The paper predicts that patients may see <5% of the $25 billion in savings that the Congressional Budget Office expects biosimilars to generate by 2018 because:

  • When savings are conveyed through a decrease in the drug’s list price, patients who pay a flat co-pay may not see any savings.
  • Few patients, if any, will benefit if the savings are conveyed as drug rebates. These are given by manufacturers to pharmacies, pharmacy benefits managers or wholesalers, often in exchange for purchasing the drug at a certain volume.
  • Medicare Part D beneficiaries may actually pay more for biosimilars. Manufacturers are required to offer 50% discounts for patients in the Part D coverage gap, the “donut hole”. But that requirement excludes biosimilars. A group of Medicare policy advisers has recently strongly supported removing this barrier to the wider use of biosimilar drugs.
  • Patients who use an interchangeable biosimilar may see the most savings, as these drugs could be assigned to a lower formulary tier with reduced cost sharing.

These financial concerns are relevant to patients who would have otherwise been treated with an originator biologic; it remains true that the savings made by payers should allow more patients to receive biologic therapy than was previously possible.

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EUROPE: Non-commercial NOR-SWITCH study supports switching to biosimilar infliximab   +

New data presented at the 2016 United European Gastroenterology (UEG) Week, show that a switch from originator infliximab (Remicade®) to a biosimilar version (CT-P13) does not adversely affect the safety or efficacy of treatment. Sponsored by the Norwegian government, the study involved nearly 500 patients at 40 sites across Norway who had been on stable infliximab treatment for at least 6 months. The results of the NOR-SWITCH study build on a growing body of real-world evidence that supports the safety and efficacy of biosimilar infliximab. Ahead of the announcement of the NOR-SWITCH findings, a white paper offering a framework for interpreting the data was issued by the Global Alliance for Patient Access.

Further new data presented at UEG Week indicated that total cost savings from the use of biosimilar infliximab in 2015 ranged from €1.35 million in Germany to €5.97 million in Spain. The Spanish findings suggested that use of biosimilar infliximab (CT-P13) could allow up to 1,085 extra patients per year to access biologic therapy.

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EUROPE: Infliximab biosimilars are safe, effective, and cheap, UK audit shows   +

Infliximab biosimilars are safe and effective and could halve the cost of inflammatory bowel disease (IBD) treatment, a report by the UK’s Royal College of Physicians has found. Use of these drugs could cut the cost of an annual course of treatment from around £10,000 (€11,700, $13,000) to around £5,000, the authors said.

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EUROPE: Ireland prepares new biosimilar policy to improve access   +

The Irish government is developing a policy aimed at increasing the use of biosimilars and helping the industry to expand domestically. Controversy was sparked by the 4-year pricing agreement the government signed in July this year with the industry body, the Irish Pharmaceutical Healthcare Association, mandating an automatic 20% price reduction for originator biologics when a biosimilar version is launched. Opponents claimed that this arrangement made it uneconomic for biosimilars to compete. It is not clear exactly what form the new pro-biosimilars policy will take, but Ireland’s Health Minister, Simon Harris, has indicated that he is looking to “Create the right market conditions that will enable the biosimilar industry to grow”.

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CANADA: New online consumer resource on biosimilars launched in Canada   +

Arthritis Consumer Experts (ACE), a national organization providing educational services for people with arthritis – has announced the launch of Biosim Exchange – the first dedicated online biosimilars resource for Canadian consumers. The resource will offer regularly updated factual information on the safety and efficacy of biosimilars, regulatory decisions, and reports on public and private health insurance formulary policies. “There is a real need for balanced, evidence-based information on biosimilars.” Cheryl Koehn, Founder & President, Arthritis Consumer Experts, said.

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CANADA: New Canadian forum calls for better access to biosimilar medicines   +

A new Canadian alliance of drug manufacturers – the Canadian Biosimilars Forum – has issued a call to both policy-makers and health system leaders to embrace the opportunity that biosimilars represent to both patients and to Canadian healthcare. "Biosimilars offer direct benefits to patients while at the same time providing sustained cost reductions to the healthcare system." one of the Forum Co-Chairs said.

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ASIA PACIFIC: Domestic Indian biosimilars market forecast to reach $40 billion by 2030   +

Following the introduction of a new regulatory policy in India, the domestic biosimilars market – currently worth an estimated $2.2 billion – is expected to grow at an accelerated pace and reach the target of $40 billion by 2030, according to a new forecast released by the Jawaharlal Nehru Institute of Advanced Studies (JNIAS). Indian biosimilars are also expected to command a 20% share of the global market, the report said.

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