German pharma group is in 'advanced discussions' with potential buyers
Merck KGaA has confirmed it intends to sell off its biosimilar drugs division, and is in "advanced discussions" with potential buyers.
The German group kicked off its biosimilar programme in 2012 via an agreement with India's Dr Reddy's Laboratories, at a time when the company was facing patent expiries on some big-selling products.
The division's most advanced project - and the only one mentioned in Merck's latest pipeline report - is a biosimilar version of AbbVie's $16bn blockbuster Humira (adalimumab) that has reached the phase III trial stage in chronic plaque psoriasis.
Sources have suggested that Merck could pick up as much as $1bn from the sale of the unit, which according to the company's annual report is expected to close before the end of the year.
Discussing the reasons behind the decision, Merck chief executive Stefan Oschmann said that the company started the biosimilars programme at a time when its proprietary drugs pipeline was looking less attractive, and when there was surplus capacity at a key biomanufacturing plant.
"In a way, getting into biosimilars was a 'plan B'," he told investors on the firm's fourth quarter results call last week. "The fact that we are now focusing on our innovative pipeline - we ourselves interpret this as a sign of confidence."
Merck invested around €130m on the biosimilar programme last year, with most of that spend going on R&D, said Oschmann.
At the time the Dr Reddy's deal was announced the biosimilars market was a big growth sector for the industry, with patent expiries for biologic products opening up a new vista of opportunities for copycat drugs.
The complex nature of biologics means that traditional generic copies are almost impossible to manufacture, while the capabilities required for developing biosimilars makes it a harder market to enter.
Despite that barrier to entry, multiple companies have started developing biosimilars, focusing inevitably on the bigger brands such as Humira, and competition is expected to be fierce. All told, more than a dozen companies, including Amgen, Samsung Bioepis, Boehringer Ingelheim, Momenta Pharmaceuticals and Sandoz, are developing Humira biosimilars, which may be a factor behind Merck's decision to vacate the sector.
Amgen picked up approval for its biosimilar Amjevita last September, although a launch date for that product is unclear because of patent disputes. In January, the EMA's Committee for Medicinal Products for Human Use (CHMP) backed approval of the Humira biosimilar under two brand names - Amgevita and Solymbic – with approval expected in the coming weeks.