HDA Media And Political Bulletin – 19 April 2016

British Biosimilars Association launched as market hots up

18 April 2016, Pharmaphorum

 

The British Biosimilars Association industry body has been formally launched. Its aim is to increase understanding and use of biosimilars. A report last month by IMS Health forecasts that biosimilars could save the US and the five largest EU countries up to $110 billion as they are considerably cheaper than their counterpart drugs.

 

British biosimilars association launched to drive awareness of biosimilars

18 April 2016, Pharmacy Biz, Neil Trainis

 

Pharmacy Biz also reports on the launch of the British Biosimilars Association (BBA). Warwick Smith, the director general of the BBA, is quoted as stating “The cost savings that can be achieved through the use of biosimilar medicines in place of the equivalent less cost-effective originator drugs will release much needed funds to the NHS when budgets are under significant pressure. The BBA’s mission is to explain the benefits of biosimilar medicines and thus to promote their use”.

Parliamentary Coverage

House of Commons, Written Answers, Drugs: Regulation, 18 April 2016

 

Asked by Justine Madders (MP): Which medicines have been reclassified from (a) prescription only medicine to pharmacy medicine status, (b) pharmacy medicine to general sales list medicine status and (c) prescription only medicine to general sales list medicine status in each of the last 25 years; for each of those medicines so reclassified what condition that medicine was designed to treat; and if he will make a statement.

 

And: For each medicine reclassified from (a) prescription only medicine to pharmacy medicine status, (b) pharmacy medicine to general sales list medicine status and (c) prescription only medicine to general sales list medicine status in the last 25 years, what the cost to the public purse was of prescribing that medicine in the three years (i) prior to and (ii) following its reclassification.

 

And: If he will make it his policy to adopt a target encouraging the reclassification of medicines from (a) prescription only medicine to pharmacy medicine status, (b) pharmacy medicine to general sales list medicine status and (c) prescription only medicine to general sales list medicine status; and if he will make a statement.

 

Department of Health

 

Answered by George Freeman (MP): The Government is committed to the continued reclassification of medicines from prescription only to pharmacy classification and from pharmacy to general sales list classification when it is safe to do so and there is a clear benefit to public health. This is an important part of empowering patients to manage their own care. The Government’s medicines regulator, the Medicines and Healthcare products Regulatory Agency, is at the forefront of moves to reclassify medicines to non-prescription and is recognised as a leader in Europe in this regard.

Over the years reclassification has been facilitated by improving the regulatory environment for manufacturers to achieve successful reclassification of their products. Amendments to legislation were introduced in 2002 to reduce the legislative burden for reclassification; new guidance was published in 2012 to streamline the process; and in 2015 a United Kingdom platform was set up to maximise stakeholder engagement with the aim of encouraging further reclassification of medicines. Patient safety remains the prime consideration in any decision to make a medicine available without prescription. We are unable to calculate the total difference in cost to the public purse following these medicine reclassifications.

The attached tables contain the information for each of the last 25 years on medicines reclassified from prescription only medicine (POM) to Pharmacy (P) medicine and P medicine to general sales list (GSL) medicine. There are no examples of medicines which have been reclassified from POM to GSL. Where relevant, brand names have been included in brackets.

The lists represent the first reclassification either from POM to P or P to GSL of the product and further extensions such as wider indications, additional pack sizes or higher strengths have not been included. Not all products listed are currently available, for various reasons, including both commercial and regulatory.

The following document(s) are referenced by this answer:

http://qna.files.parliament.uk/qna-attachments/512642/original/PQ33762 33763 33764 Reclassification of Medicines Table.docx

Full Coverage

British Biosimilars Association launched as market hots up

18 April 2016, Pharmaphorum

 

The British Biosimilars Association (BBA) industry body has been formally launched, focusing on increasing, and understanding, biosimilar use as several near-copy competitors to key big-selling drugs approach the market.

 

The news comes after a report last month by IMS Health said that England had been quick to use these cheaper near-copies of biological drugs. One example is filgrastim, which has been on the market in the country since 2009 and is used to stimulate white blood cell production following chemotherapy.

 

But pharmaphorum has heard anecdotally that there have been delays in funding for Celltrion/Hospira’s biosimilar of Johnson & Johnson/MSD’s Remicade (infliximab) for inflammatory diseases, launched just over a year ago and the first biosimilar of a monoclonal antibody to be approved.

 

Biosimilar Remicade has the potential to save the National Health Service (NHS) millions, particularly as a competitor from Samsung is poised to hit the market following a recommendation from European regulators.

 

The report forecast biosimilars could save the US and the five largest EU countries up to $110 billion as they will be considerably cheaper than the big-selling biological drugs, such as AbbVie Humira’s (adalimumab), against which they are set to compete.

 

Samsung also has an EU marketing authorisation for a biosimilar of Amgen/Pfizer’s Enbrel (etanercept) for inflammatory diseases and manufacturers are also developing biosimilars of key cancer drugs such as Roche’s Herceptin (trastuzumab).

 

Napp Pharmaceuticals, which markets the Celltrion biosimilar infliximab in the UK, said it will be a “core member” of the BBA.

 

Napp’s medical director, Dr Paul Scholfield, said: “Biosimilars have been shown to have no clinically meaningful differences from their originator biologic medicine counterparts.

 

“The landscape for biosimilar medicines has changed significantly over the past 12 months as the wealth of evidence has increased and new or updated professional guidance further supports greater uptake of biosimilars.

 

“As a core member of the BBA we will be working closely with our partners to drive a sustainable environment for a pragmatic and responsible approach to the use of biosimilars by the NHS and healthcare professionals across the UK.”

 

British biosimilars association launched to drive awareness of biosimilars

18 April 2016, Pharmacy Biz, Neil Trainis

 

The British Biosimilars Association has launched in the UK to drive awareness of a class of medicines which is set to save the NHS significant funds.

 

The new body, described by the British Generics Manufacturers Association as its “expert sector group,” will focus exclusively on biosimilars, medicines which are similar to existing biological medicines which themselves are protein-based or could be derived from living organisms.

 

There has been much excitement within the pharmaceutical industry around biosimilars, some of which have arrived on the UK market after the patent expiries of biological medicines.

 

There are seven biosimilar molecules on the UK market; somatropin, follitropin alfa, filgrastim, infliximab, epotein alfa, insulin glargine and etanercept.

 

“However, this is set to increase due to a number of factors including patent expiries, increasing clinical awareness and knowledge as well as supportive guidance from organisations such as the National Institute for Health and Care Excellence (NICE) to generate confidence in using these products,” the BGMA said.

 

Warwick Smith, the director general of the BBA and the BGMA (pictured), said: “It is vital that the UK maximises the potential offered by the increased use of biosimilar medicines.

 

“The cost savings that can be achieved through the use of biosimilar medicines in place of their equivalent less cost-effective originator drugs will release much needed funds to the NHS when budgets are under significant pressure. The BBA’s mission is to explain the benefits of biosimilar medicines and thus to promote their use.”

From Factory to Pharmacy

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