Last week, Reuters reported that Merck KGaA is “exploring a sale of its biosimilars unit” due to fierce competition from larger players such as Novartis and Pfizer, citing unnamed “people familiar with the matter."
The German drugmaker told Biopharma-Reporter its policy is to not comment on rumours, with spokesman Gangolf Schrimpf adding that a similar response had been given to the news wire.
The Reuters sources priced the business at “as much as $1bn,” however, without knowing who these people are such valuations should be taken with a pinch of salt.
Instead, Biopharma-reporter decided to look at what any potential buyer of Merck’s biosimilar unit would get.
Swiss biz
Merck set up its biosimilars unit in 2012 and located it in Canton de Vaud, Switzerland. The firm said it intended to leverage its nearby biologics manufacturing facilities in Aubonne and Corsier sur Vevey to support the business.
In 2014, it invested €100m ($111m) into the unit, and pledged a further €130-150m for the following year to support Phase II trials of a version of AbbVie’s best-selling monoclonal antibody Humira (adalimumab).
The candidate, MSB11022, began a global Phase III trial earlier this year and is the only molecule in development according to the pipeline presented on Merck’s website.
The firm also established a partnership with Dr. Reddy’s in 2012 to co-develop a portfolio of oncology biosimilars in oncology, and in 2014 the company partnered with Bionovis to develop biosimilars for the Brazilian market.
And according to a 2014 presentation, Merck has an in-licensing agreement for a late-stage biosimilar details of which have not been disclosed.
In addition, according to the firm’s report in 2015 “further biologics were added to the pipeline to secure an attractive biosimilars portfolio and a sustainable biosimilars business.”
The 2014 presentation also stated Merck was at the registration stage for MSB11202, an undisclosed a late-stage auto-immune disease biosimilar candidate the firm licensed from an external developer.
According to the Evaluate group, MSB11202 is a version of Roche’s Mabthera (rituximab). However, Schrimpf declined to comment on the molecule or Merck’s current involvement.
Humira biosimilars
However, he did confirm that the adalimumab biosimilar, MSB11022, is Merck's most advanced project.
Humira’s worldwide sales were more than $14bn in 2015. However, the market potential for any Humira biosimilar is likely to face competition - there are around 30 versions of adalimumab in development according to a report from BioPlan Associates.
Several Humira biosimilars are already available – Zydus Cadila’s Exemptia in India, for example – while Amgen’s Amjevita was first to receive US approval in September.