Follow-on biotechnology drugs - also referred to as “biosimilars” (the European Union definition) or “biogenerics” - should carry the Medicines and Healthcare products Regulatory Agency’s (MHRA) “black triangle” symbol, denoting that a medicine should be intensively monitored for adverse drug reactions. And, with periodic reviews, the triangle should remain unless the safety evidence is clear that it can be removed, Dr Brian Iddon, Labour MP for Bolton South-East, told the House of Commons during an adjournment debate this month.

Late last year, a group of five parliamentarians led by Dr Iddon conducted a review of biosimilar drugs and the implications of making them available to patients in the UK. Shortly before Christmas they published their findings, which called for new safety measures to ensure that prescribing and pharmacovigilance procedures are sufficient to safeguard best practice and protect patients.

The panel also believes that biological drugs, whether the parent drug or a biosimilar, should be prescribed and dispensed by their brand names only, Dr Iddon told the House. “It is preferable, in our opinion, for a patient to be established on one biological drug by their doctor and for the patient to remain on that drug for the duration of their treatment unless adverse drug reactions are noticed,” he added.

Moreover, the panel is calling for an “urgent” ban on substitution of biologicals until effective safeguards can be relied on. “With the existing pharmacovigilance systems, it may not be possible to distinguish accurately or trace precisely the product dispensed by the pharmacist to the patient, should they suffer an adverse drug reaction,” he said. It also believes a publicity campaign is needed to raise public awareness of the risks of substitution, and for patients to be actively encouraged to monitor and report to their doctor any adverse drug reactions that they may experience.

Dr Iddon told the House that the public’s “extremely limited” knowledge about biogenerics was one reason why he applied for the adjournment debate. So far, patents have run out on just five of the over 200 biotechnology drugs which are being used to treat around 325 million patients worldwide with various cancers, HIV/AIDS, neurological disorders, heart disease, diabetes and rare genetic diseases, but that number will increase significantly in the next few years, he said.

A biosimilar costs around £5-£20 million to develop, compared with £500,000-£1 million for a generic drug, and with a timeline similar to the development of the parent biological drug, said Dr Iddon. He forecast that savings to the National Health Service (NHS) from the use of biosimilars will be around 10%-20% but added that, given that biological drugs are more expensive than conventional medicines, this could be a considerable overall saving to the NHS.

Responding, Health Minister Dawn Primarolo told the House that a number of initiatives are now underway to ensure the safety of biosimilars on the market can be effectively monitored.

Brand names
The MHRA encourages biosimilars manufacturers to give them brand names so that there is no possibility of the pharmacist substituting another biosimilar when dispensing a prescription, she said and, turning to Dr Iddon’s concern that pharmacists may be automatically substituting biosimilars for prescribed, branded products, the Minister pointed out that UK medicines legislation does not allow such substitution without first agreeing that with the prescriber. There is no concrete evidence that such substitution is currently happening, she said, but told Dr Iddon that if he or his report had such evidence, she “would be interested in considering it.”

Speaking ahead of the debate, Warwick Smith, director of the British Generic Manufacturers Association (BGMA), pointed out that biosimilars are assessed by the same regulatory agency as originator biopharmaceuticals, “with the same scientific rigour, using the same regulatory systems, to ensure that they match the originator product in terms of quality, safety and efficacy.”

Moreover, without competition from biosimilars, prices of originator biotechnology products would remain artificially high. “We cannot afford not to have competition from biosimilar products. The 60+ age group will grow by at least 25% by 2015 and will cost on average three to four times more on medicines than when they were 30,” said Mr Smith.

Last December, after Dr Iddon and his colleagues produced their report, the BGMA said it had not been asked to contribute to the review (which was funded by Amgen) nor, it believed, had any representative of the biosimilars industry. Therefore, the evidence taken had not been balanced, it stated.