After Covid-19 vaccines, Roche’s tocilizumab is seeing an unprecedented demand and pressure on its global supplies.

And this has lead to agencies like Unitaid and World Health Organization to call for a technology transfer to facilitate more companies to make the product and shore-up supplies. Roche sells tocilizumab in India through Cipla, a deal formalised in 2018. Tocilizumab (brand name Actemra/RoActemra), is an IL6 inhibitor recommended by the WHO in June, to treat severe Covid-19 cases. It plays a key role in decreasing mortality and reducing the need for invasive mechanical ventilation among severely ill patients, when delivered alongside oxygen and corticosteroids.

But days ago, Roche cautioned of a global shortage of these drugs in the weeks and months ahead, “due to the unprecedented surge in worldwide demand, with US demand spiking to well-beyond 400 per cent of pre-Covid levels over the last two weeks alone”.

This, Roche said was “due to global manufacturing capacity limits, raw material supply constraints, the complex, labour-intensive process of manufacturing biologics, and the dynamically evolving nature of the pandemic”.

Reacting to Roche’s statement, the two UN agencies urged Roche “to facilitate technology transfer and knowledge and data sharing to broaden access to this important treatment”. In fact, the WHO has called for an Expression of Interest to expand the number of quality-assured manufacturers of the drug and thus increase global supplies.

Not asserting patents

On whether Roche was exploring production alliances in India or elsewhere, the multinational told Business Line: “In the case of Actemra, we have taken the decision to not assert any patent rights against the use of Actemra to treat Covid-19 in LMICs (low- and middle-income countries) during the current pandemic.” This decision was taken “to ensure that companies who are ready and able to produce biosimilar versions of Actemra could do so without delay caused by licensing negotiations for a voluntary license and without any legal uncertainty in relation to our (Roche and Chugai) patent rights”, the company said.

During 2021, Roche supplied Actemra/RoActemra at levels that have increased by more than 100 per cent compared to the pre-pandemic period. And, In India, “since the start of the pandemic, we have made available approximately 2,000 per cent above the normal supply of Actemra”, it added.

Call to lower price

In July, Médecins Sans Frontières/Doctors Without Borders (MSF) had called on Swiss pharmaceutical company Roche, the world’s sole producer of the drug, to lower the price of the drug to make it affordable and accessible. MSF urged the company to “share the know-how, master cell lines and technology needed to produce this drug with other manufacturers across the world to ensure supply and improved access”.

Roche said that even ahead of data on Actemra/RoActemra in Covid-19 becoming available in 2020, it had scaled up manufacturing and “contracted with all available large-scale manufacturers around the world to transfer our technologies – a very complex process, which is still ongoing – and maximising production.” Its largest manufacturing facility is dedicated exclusively to producing treatments for patients with Covid-19, it added.

Related Topics