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Lilly and Boehringer diabetes biosimilar sees EU approval

Published on 11/09/14 at 05:40pm
Lilly image

Lilly and Boehringer Ingelheim’s insulin glargine product has been shown the green light by the European Commission (EC).

The copycat version of Sanofi’s best-selling insulin makes it the fourth diabetes product approved in the EU under a Lilly-Boehringer alliance.

The combined firm's own biosimilar version of Lantus will be made available in a pre-filled pen along with cartridges.

The news will be a major blow to Sanofi as its original drug is its biggest-selling product, generating annual sales of around $8 billion.

"The marketing authorisation for this insulin glargine product in Europe is a significant achievement for the Lilly-Boehringer Ingelheim Alliance,” says Enrique Conterno, president at Lilly Diabetes.

“We believe that insulin glargine will continue to be widely used for many years, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine, he adds."

Manufactured by Lilly, the treatment comprises a type of basal insulin intended to provide log-lasting blood sugar control between meals at night.

The alliance between Lilly and Boehringer was announced in 2011 through a multi-million dollar collaboration that saw them develop a mid-to-late-stage pipeline of four diabetes compounds. Their new product is the first insulin treatment approved through the EMA’s biosimilar pathway.

The firm’s first joint venture was to develop the type 2 diabetes drug Trajenta (linaglipton), which saw European Medicines Agency (EMA) approval in August of 2011. A year later scientists in Sweden suggested that the drug could one day be used to minimise the effects of brain damage following stroke.

In a recent Institute of Health Studies (IMS) report it was suggested that biosimilars are expected to increase market share within biopharma from 1% in 2014, to 10% in 2020 – representing an increase from $1.9 billion to around $25 billion.

Aside from any potential financial benefits there is still concern over the use of biosimilars; the Food and Drug Administration (FDA) recently noted that biological products can pose scientific and technical challenges associated with the large molecular structure and manufacturing of biological products.

Widening market

According the World Health Organization an estimated 347 million people worldwide have diabetes, including 2.9 million in the UK alone.

Last month Pharmafile reported that the cost of diabetes treatment in England had soared after ‘Prescribing for Diabetes’ released showed the net ingredient cost for managing diabetes amounted to £803.1 million in 2013-14.

Along with the potential loss of sales, Sanofi is also set to lose patent protection for its original insulin drug early next year. Outselling its closest rival, Novo Nordisk’s Levemir, Lantus currently dominates the insulin market.

In 2014 Sanofi filed a lawsuit against Lilly accusing the frim of infringing four patents on its drug Lantus and Lantus SoloStar. Whilst EU approval has now been given the go-ahead, Lilly-Boehringer will need to settle its lawsuit and land US approval in order to compete with the Sanofi.

Tom Robinson

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