Making cutting edge treatments accessible to more patients, is one of the greatest challenges facing the healthcare system and biosimilars are playing a part in making this possible. In this issue, we speak to Fabio Kellett, Director of Biosimilars at Napp Pharmaceuticals Ltd about the development of biosimilars and how they are enabling more patients to be treated.

Background on biosimilars

“Biosimilars have been around for over a decade,” explains Fabio. “Whereas generic medicines contain active ingredients that are chemically identical to the originator medicine, biosimilars, as the name suggests, are similar, but not identical to the original biologic. Since biological products are a complex combination of materials which are active substances derived from living cells or organisms, they may show a certain degree of variation, even between batches of the same product.

“A biosimilar medicine is a biological medicine which has been shown not to have any clinically meaningful differences from the reference medicine in terms of quality, biological activity, safety, efficacy and immunogenicity.”

Making a positive difference

“The NHS is one of the biggest health care economies in the world, and understandably empirical evidence is required to make new treatments available. The beauty of biosimilars is that they enable this to happen sooner, so biosimilars are making a positive difference to patients and the NHS, as more patients can access more advanced treatments.

“This is because, when compared to the high cost of developing and manufacturing medicines, biosimilars are cost-effective. The NHS has been able to make huge savings by using the best value treatments available, whether they are generics or biosimilars. Collectively the use of generics and biosimilars are estimated to have saved the NHS a staggering £700m since 2016.

Almost a century of expertise

“Partnership working is central to what we do. Napp Pharmaceuticals has been working closely with the NHS since its inception. In addition to strong partnerships at all levels of the NHS, we work with policy-makers, trade associations and partners across the healthcare and pharmaceutical sectors. We know how to navigate its complexities and we’ve shaped our structure to its unique needs, so as the NHS changes, we can too.

“Our services go far beyond bringing a product to the market. We dedicate our time and resources to providing information, education and support, because we believe that adding value is about more than just price. By providing value through support programmes and educational activities, we can build confidence in biosimilars and the role they can play in improving patient outcomes. It is this wraparound service and our commitment to embedding biosimilars, that makes Napp stand out from our competitors and so often makes us the partner of choice.

“We foster a flexible culture at Napp where our people thrive on the ability to be agile and autonomous in response to the needs of our partners. What speaks volumes about the company is the low turnover of staff, as people stay with us for the long term. Few biosimilars teams in the industry have stayed as one unit for so long, providing stability for our customers and meaning our decades of experience informs every project.”

Pioneering biosimilars

“Our agility and autonomy were instrumental to us becoming one of the first pharmaceutical companies to launch a biosimilar monoclonal antibody (mAb). A more recent phenomenon within the family of biosimilars, the first of the mAbs became available in Europe as recently as 2015, when we brought the first large molecule biosimilar for rheumatoid arthritis to the UK market.

“Larger, more complex structures than other biosimilars, you might equate developing mAbs with working on a jumbo jet rather than a small car. Used by the immune system to fight diseases, mAbs have proven particularly effective in treating cancer and rheumatoid arthritis.

“Our biosimilars capability has remained a central part of our business and this year Napp became the third largest provider of mAbs in the UK.”

Delivering better health outcomes

“Overall, given biosimilar mAbs provide equivalent treatment, but are more cost-effective than the originators, they provide benefits for both patients and the NHS. More people can benefit from treatment, potentially sooner, thereby delivering better health outcomes, as well as freeing up precious resources for additional research work.

“In short, biosimilars help to move medicine forward, which is our purpose as an organisation and they have a significant role to play in making the NHS sustainable. That’s why we’re focused on introducing more biosimilars over the coming years.”