by Helen Collis
LONDON, Nov 3 (APM) - All stakeholders involved in biosimilars uptake need to educate their peers on the new drugs, including their differences from generics, their development, comparability with originator products and the regulatory pathway, according to Amgen’s European head of regulatory policy.
Rather than multi-stakeholder-produced material attempting to speak in a language everyone understands, effective communication to each stakeholder, from patients, to doctors and to nurses, would be best done by members within each profession, said Dr Virginia Acha.
Speaking to APM in a telephone interview on Friday, Acha said: “What would be really helpful would be if stakeholders themselves can meet us half way and educate their peers.”
Several recent reports, including one by GfK Market Access (APMMA 40280), have underlined the importance of effective communication on biosimilars, to educate those who will be involved in their use, and to build experience and trust in prescribing and using the drugs. This has been highlighted as a key barrier to market access success for the drugs.
“But the situation remains, we have a lot of work to do to improve understanding with physicians and patients and nurses to bring this together,” Acha said.
One of the best examples of effective communication on biosimilars, according to Acha, is material developed for patients by patients - by the International Alliance of Patient Organisations.
“They interviewed regulators and different academic experts and they put together their own brochure. That’s ideally the best way to go,” she said.
“If some of these stakeholders can meet us half way and provide this kind of information, that’s the best way to reach their audience.”
Another example, she said, was a recent article written by members of the Biosimilars Working Party of the EMA in the journal Blood - explaining how biosimilars work to its audience, which is primarily doctors.
Acha pointed out that building trust in the use of biosimilars was more than simply explaining how the medicines were highly similar versions of the originator product.
Prescribers and patients first need to learn how biologicals are manufactured, and then understand how biosimilars are developed to perform the same biological function as the originator, with their safety, efficacy and comparability demonstrated in clinical trials.
In addition, stakeholders globally need to be on board with the different regulatory environments for biosimilars across Europe and elsewhere, compared with their originator products.
“We are trying to explain to our colleagues how biotherapeutics are manufactured and then explain that there is another way of regulating these versions of existing biologicals.”
She said they were trying to do this through multi-stakeholder meetings, but it was a “tough challenge”.
Aside from doctors, Acha said it was just as important that all healthcare workers, from nurses to pharmacists, are educated and understand the biosimilars market, although she said the latter was one of the most engaged in the process.
“Pharmacists have been on the issue for quite some time, but it’s more of a challenge getting doctors on board,” she said.
“That’s a key part of it - engaging well with people who are going to be prescribing or using your product so that they can make the right choices,” she added.
Amgen has several biosimilars in development, including for the big blockbuster monoclonal antibodies which will begin to lose patent from next year.
A company spokesman recently told APM it aims to launch six monoclonal biosimilars from 2017, including near-copies of AbbVie's Humira (adalimumab), Johnson & Johnson/MSD's Remicade (infliximab), Roche's Herceptin (trastuzumab), Avastin (bevacizumab), Rituxan/MabThera (rituximab) and Merck KGaA's Erbitux (cetuximab). (APMMA 40061)
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