BBA formed to help U.K. catch up on biosimilars scene

LONDON – Biosimilars companies have joined forces to drive uptake of their products in the U.K., securing the backing of the National Health Service's (NHS) chief pharmaceutical officer in a push to promote competition against higher-price originators.

The British Biosimilars Association (BBA) said its aim is to increase awareness and understanding of biosimilars amongst clinicians, in order to increase their use. Currently, the U.K. lags behind other countries in Europe in the adoption of biosimilars, according to BBA.

NHS England's chief pharmaceutical officer, Keith Ridge, welcomed the formation of BBA, saying there is potential to increase patient access to biologics whilst reducing costs. "It is important that clinicians are aware of their potential and that wherever appropriate biosimilar competition is encouraged," Ridge said.

Biosimilars offer choice, clinical benefits and cost savings, said Warwick Smith, director general of BBA. "At present, six of the top 10 medicines expenditures by the NHS are on biological drugs. With many due to come off-patent in the next few years, biosimilars offer a real opportunity to increase patient choice and access," Smith said.

To date, seven biosimilars – somatropin, follitropin alfa, filgrastim, infliximab, epoetin alfa, insulin glargine and etanercept – have made it to market in the U.K., since the first approval a decade ago. The number is set to increase as originator products lose patent protection.

The NHS has taken steps to drive up the use of biosimilars, publishing a guide to inform staff on their adoption last year. (See BioWorld Today, Oct. 6, 2015.)

In addition, a number of national and regional meetings have been held with key audiences and the health technology assessment body, the National Institute of Clinical and Care Excellence (NICE), has published guidance on implementing specific products, including the first biosimilar of a big-selling monoclonal antibody, infliximab (Remicade).

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The founding members of BBA are Sandoz Inc., Napp Pharmaceutical Group Ltd., Accord Healthcare, Teva Pharmaceutical Industries Ltd., Boehringer Ingelheim GmbH and Allergan plc.

To bolster its claim of increasing access while reducing costs, the association pointed to research sponsored by Novartis AG and carried out by market analysts IMS Consulting Group, looking at the need to build competitive markets to capture the full value of biosimilars.

Almost 50 biosimilars are in development currently. The countries that are best placed to extract value from those products are those that provide motivation for manufacturers to participate over the longer term, and put physicians at the heart of decision-making on their use, IMS said.

Germany has been the most successful European country in stimulating biosimilar prescribing, while Austria, where some biosimilars have been subject to mandatory price reductions, has seen some products effectively excluded from the market.

IMS identifies eight biologics that are due to lose patent protection from 2015 to 2020. In the absence of biosimilar competition, the leading European markets of Germany, France, Italy, Spain and the U.K. are likely to spend €47 billion (US$52 billion) on those eight originator products from 2016 to 2020. With effective biosimilar competition, payers in the five markets could make savings of €10 billion over the same time frame, according to IMS.

To access its share of those savings, the BBA said the U.K. policy should require that clinicians routinely prescribe biosimilar medicines for new patients, rather than the more expensive originator products. Clinicians also should be required to consider switching existing patients to a more cost-effective biosimilar medicine when one becomes available.

In addition, BBA is calling for changes to procurement rules. While biosimilars cannot offer the same 70 percent to 90 percent price reductions seen with traditional generics, the typical 30 percent saving with biosimilars comes off a comparatively high base. And, inevitably, originator companies will come under pressure to offer discounts and rebates as competitor products reach the market.

However, the current procurement system in the U.K. bases decisions primarily on price, encouraging rapid price reduction, which is not sustainable for biosimilar medicines, since it does not take into account the costs and complexities of manufacturing and quality assurance.

"A healthy competitive market will ensure savings are delivered to the NHS in the long term, but this requires sufficient financial returns for enough biosimilar manufacturers to compete over a sustained period," BBA said, calling for changes to the procurement system.

Ridge said as the number of biosimilars increases, the NHS needs to plan for timely and cost-effective introduction. "NHS England supports the appropriate use of biosimilars, which will drive greater competition to release cost efficiencies to support priorities for patient care generally," he said. More patients will be treated with biologics and there will be "headroom" in the drugs budget for innovative therapies.

The lower cost of biosimilars will have an impact on NICE's quality adjusted life year, or QALY, formula for assessing the cost-effectiveness of drugs, such that a biosimilar may pass NICE's scrutiny when the equivalent originator product has previously been judged not to be cost-effective. As a result, treatments may be available on the NHS which might otherwise not have been reimbursed.

NICE's guidelines to support the systematic introduction of biosimilar infliximab to replace Remicade explicitly describe how to manage a wholesale switch from an originator to a biosimilar, including recommendations on educating clinicians, engaging patients' groups and putting together a business case. They are based on a couple of case studies of hospitals that have made a switch from Remicade to either Inflectra (Hospira Inc.) or Remsima (Celltrion Inc.), the two brand names for the same biosimilar version of infliximab.

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