Accord Launches 2 Biosimilars in the UK, Expands Partnership With Henlius

In the past 2 weeks, Accord Healthcare said that it has launched 2 oncology biosimilars in the United Kingdom, including its biosimilar pegfilgrastim and trastuzumab products.

Accord’s launch of its trastuzumab biosimilar (Zercepac) comes after it received regulatory approval from the European Commission (EC) in July 2020.

The EC granted marketing authorization to Accord’s pegfilgrastim (Pelgraz) in September 2018.

Cancer is a leading cause of death in the United Kingdom, Accord explained in a press release. Although medical advances have allowed patients with cancer to live longer, the cost of cancer care in Europe has doubled over the last 25 years, amounting to about €103 billion (approximately $120 billion).

In addition to these 2 products, Accord has 2 other biosimilars, including a biosimilar filgrastim (Accofil), which was approved for marketing in Europe in 2015 and was the company’s first biosimilar to receive European marketing authorization.

Expanding Zercepac Partnership

Zercepac, which references Genentech’s Herceptin, was developed in collaboration with Shanghai Henlius Biotech.

Recently, Shanghai, China-based Henlius announced that it would amend its original agreement with Accord to allow the United Kingdom–based company to have the commercialization rights for Zercepac in the United States and Canada.

Originally, the 2 companies entered into a license agreement for Zercepac in 2018. Under the agreement, Accord was granted exclusive commercialization rights in 53 countries including the United Kingdom, the European Union, 17 countries in the Middle East and North Africa, and some Commonwealth of Independent States.

According to the amendment, Accord US will give Henlius milestone payments that will include an upfront payment of $27 million, a regulatory milestone payment of $13 million, and a commercial sales milestone payment of $25 million for every $500 million of cumulative net sales for Zercepac.

Henlius will also be eligible to receive a tiered royalty payment of up to 50% of any future net profit of Zercepac.

More on Pelgraz

Referencing Amgen’s Neulasta, Pelgraz has received indications for treating patients with cancer who have febrile neutropenia as a result of undergoing cytotoxic chemotherapy and provides patients with a one dose per chemotherapy cycle regime with a self-injectable device that allows the drug to be administered at home.

“Evidence shows that travelling to, and attending hospital visits, are one of the major contributing factors that negatively impact the quality of life for people living with cancer. Reducing the number of times that a patient must visit the clinic or hospital, at a time when they are living with the side-effects of chemotherapy and when their immune systems are compromised, must be a priority for patients and their healthcare team," Professor Hartmut Link, professor of Medicine and external faculty at University Medical Centre in Hannover, Germany, said in a statement.

Pelgraz was the second pegfilgrastim biosimilar to receive regulatory authorization.

More on Zercepac

Zercepac received indications for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer.

"We are proud to launch Zercepac in the UK and offer healthcare professionals an additional option of this vital oncology medicine,” said Anup Sidhu, specialty brands director of Accord. “This is the launch of our first monoclonal antibody, reinforcing our commitment to ensuring improved patient access whilst also helping to alleviate some of the pressures on overstretched health systems.”

Zercepac marks Accords’ first monoclonal antibody product despite having more than 30 oncology treatments available across Europe.

The trastuzumab molecule is currently available in Germany, Portugal, and Spain.

In August 2020, Helius received regulatory approval for Zercepac for marketing in China.