Biosimilar Bulletin: EU Success for Sandoz, Amgen Stumbles Stateside

Sandoz says it will use a third-party manufacturer as its proposed Humira biosimilar receives recommendation in Europe. Meanwhile, the US FDA has rejected Amgen’s proposed Herceptin biosimilar.

Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Halimatoz, Hefiya and Hyrimoz – all versions of AbbVie’s best-selling Mab Humira (adalimumab) submitted by Novartis subsidiary Sandoz.

“To ensure the majority of eligible patients gain access to our biosimilar medicines as soon as possible, we sometimes request multiple marketing authorizations covering specific indications,” Sandoz spokesperson Chris Lewis told BioProcess Insider.

“Sandoz and Novartis believe strongly in the value of patents as a means of driving innovation, including new uses for biosimilars. We also believe in bringing competition to market as soon as patents expire.”

If approved by the European Commission, the products will become the latest addition to Sandoz’s EU portfolio, joining the like of its Enbrel (etanercept) biosimilar Erelzi, and its version of Mabthera (rituximab), Rixathon.

Adalimumab Contract Manufacturing

Combined with the Novartis network, Sandoz has biologics manufacturing capabilities in Kundl and Schaftenau in Austria, and Menges in Slovenia.

But according to Lewis, Halimatoz, Hefiya and Hyrimoz will be made by an undisclosed contract manufacturing organization (CMO).

“In order to reach patients and payors as soon as possible, our proposed biosimilar adalimumab will be manufactured at a third-party site. Production will be fully GMP compliant and will adhere to Sandoz quality standards.”

He added: “It’s too early to discuss supply plans.”

Adalimumab Market

In 2017, global sales of Humira brought AbbVie revenues of US$18.3 billion (€15.6 billion), with non-US sales contributing $6 billion, including around $4.1 billion from Europe.

While AbbVie is not expecting biosimilar competition in the US until 2022 at the earliest, in Europe competition could arrive later this year. Sandoz is just one of several firms lining up to take a share of the market. Others include Samsung Bioepis (with its approved product Imraldi), Amgen (with its approved product Amgevita), and Boehringer-Ingelheim (with its approved product Cyltezo).

Despite the increasing competition, Lewis said Sandoz expects to take a large slice of the market.

“We believe we have the combination of manufacturing excellence, robust underlying science and understanding of customer needs to give doctors and patients confidence in this new treatment option, once approved.”

Trastuzumab: Pfizer Thumbs Up, Amgen Thumbs Down

The EMA also recommended Pfizer’s biosimilar version of Roche’s breast cancer drug Herceptin (trastuzumab), Trazimera.

Trazimera will become Pfizer’s fourth biosimilar and first therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA.

“It is too early to confirm the exact manufacturing location, but it is planned that Trazimera will be manufactured in production facilities across Europe,” spokesperson Thomas Biegi told us.

Amgen, however, was less successful with its trastuzumab biosimilar – ABP 980 – after it received a US Food and Drug Administration (FDA) complete response letter (CRL) in response to the Biologics License Application (BLA).

“We will work closely with the FDA to bring this important medicine to patients in the US. We do not expect this to impact our US launch plan.”

Earlier this year, ABP 980 received CHMP recommendation for approval in Europe.