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September 2016

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GLOBAL: New systematic review of global data finds branded and biosimilar TNF-α inhibitors equally safe and effective   +

A new Johns Hopkins Bloomberg School of Public Health systematic review, published in the Annals of Medicine, has reported that biosimilars for the treatment of rheumatoid arthritis and other autoimmune diseases appear to be as effective and safe as their branded equivalents. Researchers conducted a systematic review of 19 eligible studies (Phase I, Phase III, and observational studies) comparing the original and biosimilar forms of TNF-α inhibitors. The data from these studies indicated that biosimilar drugs have safety and effectiveness profiles that are very similar to those of their branded counterparts. “Our study should reassure clinicians and patients and, importantly, the folks who pay the bills — insurance companies and government programs like Medicare” the authors said. “Hopefully this will encourage the brisk adoption of these products. There is no question that greater competition in this market will benefit patients, prescribers, and society in the long run.”

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GLOBAL: Roche focuses on subcutaneous versions of leading biologics to bolster defense against biosimilar competition   +

Now that the original intravenous formulation of rituximab (Rituxan®/MabThera®) has reached (or is soon to reach) patent expiry in many markets, Roche is pursuing approval of new indications for its subcutaneous version – which still has several years of patent protection left. They took the same approach with trastuzumab (Herceptin®) in the belief that it will help protect against biosimilar competition and limit sales erosion. Administering biologics under the skin rather than through intravenous infusions can reduce delivery times significantly without compromising efficacy or safety: 7 minutes compared with 2.5 hours for rituximab, and 5 minutes compared with 90 minutes (initial infusion)/30 minutes (subsequent infusions) for trastuzumab.

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UNITED STATES: Leading pharmacy benefit manager CVS drops coverage of two branded biologics in favor of biosimilars   +

CVS Health Corp. is embracing biosimilars in an attempt to combat rising prescription drug costs. CVS, whose Caremark unit administers drug-benefit plans for employers and insurers, has said that, from 1 January 2017, it will drop coverage of branded filgrastim and insulin glargine and instead cover their licensed biosimilar versions. Best known as a retail pharmacy chain, CVS is also a major player in the pharmacy benefit management industry, overseeing drug spending for US employers, health insurers, and labor unions. The move by CVS is the latest indication that US health insurers and pharmacy benefit managers are eager to reap savings from biosimilars. CVS Chief Medical Officer Troyen A. Brennan said biosimilars are typically priced 10‒15% cheaper than originators but that CVS has negotiated additional discounts. “We want to signal that this biosimilar movement is real,” Dr Brennan said in an interview. “We have big hopes for [biosimilars] to reduce drug costs overall.”

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UNITED STATES: FDA tells Sandoz to resubmit their application for biosimilar pegfilgrastim   +

Sandoz has received a complete response letter (CRL) from the FDA for their biosimilar pegfilgrastim candidate. This effectively means that the current application has been rejected and more information has been requested prior to resubmission. This will be a blow to Sandoz, which has been highly successful in the biosimilars field to date, and perhaps more widely to other biosimilar manufacturers, just when it looked like regulatory decisions were becoming a little more predictable. However, other companies have received CRLs, notably Pfizer’s new Hospira unit, whose biosimilar version of Amgen’s kidney disease drug Epogen® (epoetin alfa) was rejected last year. It is unclear what the Sandoz CRL refers to, and whether the issues have to do with a clinical trial or manufacturing concerns. In a statement released last year, Sandoz said it had conducted three pivotal clinical trials on its biosimilar: one pharmacokinetic and pharmacodynamic study in healthy volunteers, and two comparative efficacy and safety studies in patients with breast cancer (PROTECT 1 and 2).

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UNITED STATES: AbbVie begins litigation against Amgen over adalimumab biosimilar   +

Amgen's biosimilar of adalimumab, ABP 501, which was given unanimous support by the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee in July, now faces significant litigation by AbbVie, manufacturer of the originator, Humira®. AbbVie's patent infringement lawsuit against Amgen, which was filed on 4 August 2016 in the US District Court for the District of Delaware, claims ABP 501 infringes 61 of the 100+ patents that cover Humira. Only 10 patent infringements are cited in the complaint at this first stage of the process but AbbVie has promised a second wave of litigation involving dozens of additional patents. The suit also contends that, although Amgen provided its abbreviated biologic license application to AbbVie when the parties began exchanging patent information in February, it did not provide any other information that describes the process or processes used to manufacture ABP 501 as required by the Biologics Price Competition and Innovation Act (BPCIA).

Amgen has been the plaintiff in several suits seeking to protect its branded biologics against biosimilar competitors. It has complaints pending against Sandoz claiming that biosimilars to Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Enbrel® (etanercept) infringe its patents; a complaint against Apotex Inc. over its Neulasta biosimilar; and a complaint against Hospira Inc. (now Pfizer Inc.) over its Epogen® (epoetin alfa) biosimilar. Amgen’s role is reversed in the Humira litigation, a fact AbbVie highlights in disputing Amgen's arguments. It therefore seems that, although ABP 501 may shortly receive FDA approval, its launch in the US may be subject to significant delay.

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UNITED STATES: The Pharmaceutical Research and Manufacturers of America accepts Teva, a maker of generics, as a member   +

In a move that underscores the changing landscape of the pharmaceutical industry, the chief US trade group has officially accepted one of the world’s largest generic drug makers into its ranks. Teva Pharmaceuticals has become a member of the Pharmaceutical Research and Manufacturers of America, which has traditionally been a staunch defender of brand-name companies. The decision to accept Teva has surprised some industry watchers, given the historical rivalry between brand-name and generic manufacturers. The move, however, is not all that unexpected, if only because – especially in the biosimilars field – the lines are beginning to blur and the strategic interests of brand-name and generic companies are increasingly overlapping.

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ASIA PACIFIC: Japanese Biosimilars Association launched   +

The establishment of a dedicated Biosimilars Association has been announced in Japan. Bringing together stakeholders from industry, government, and academia, the association aims to contribute to the country's healthcare by clarifying the optimal role of biosimilars, sharing knowledge and experience, and discussing obstacles to their acceptance.

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EUROPE: Irish government reaches controversial deal with pharma firms on biologic drug prices   +

A new agreement has been reached between the Irish government and the Irish Pharmaceutical Healthcare Association (IPHA), which has been promised to result in savings of around €750 million. The 4-year deal is intended to facilitate patient access to new and innovative medicines, including biologics. Under the deal, biologic medicines that have lost exclusivity will be automatically discounted by 20% when a biosimilar competitor is launched. In addition to the price cut, suppliers of off-patent biologics must pay the Health Service Executive (HSE) a rebate of 12.5% of the value of the reduced price.

However, the Healthcare Enterprise Alliance (HEA), which represents the generics and biosimilars sector, says the agreement blocks competition, making it uneconomic for biosimilars to enter the market. “The inclusion of an artificial pricing clause that blocks better value biosimilar medicines entering the market is profoundly disappointing,” HEA president Sandra Gannon said. “It leaves Ireland one of the only countries in the world preventing competition in this part of the medicines market. We have seen in recent years what can be achieved by bringing a reforming ethos to medicine prescription, dispensation and pricing. This agreement halts that momentum.” To date, Spain has been the only other European Union country to mandate that manufacturers of originator biologics must drop their prices upon patent expiry.

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