Pfizer on U.S. launch plans for biosimilars of Roche's cancer drugs Avastin, Rituxan and Herceptin

Country : U.S.

Keywords :
LONDON, 24 Jan (APM) - Pfizer has launched biosimilar versions of Roche's cancer drugs Avastin and Rituxan in recent weeks in the U.S., while a version of Roche's Herceptin is expected to launch next month.
All the biosimilar drugs are expected to launch at the lowest list price for their respective products, said Pfizer in a Thursday statement.
Angela Lukin, regional president, North America oncology at Pfizer said the products can "create significant savings for the U.S. healthcare system".
"We look forward to working with payers and providers to deliver these important medicines to patients that are living with certain cancers and autoimmune conditions," she said.

Biosimilar Avastin

Zirabev, a version of Avastin (bevacizumab), launched in the U.S. at the end of 2019 at a wholesale acquisition cost of $61.34 per 10 mg, representing a 23% discount on the originator product, which made 2.37 billion Swiss francs (€2.21 billion) in the U.S. for the first nine months of 2019.
Zirabev was approved in June for five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer (APMHE 63515).
It will also compete with Amgen and Allergan's biosimilar, known as Mvasi, which launched at the end of July 2019 (APMHE 63764).
Samsung Bioepis has also filed for a biosimilar version of bevacizumab (APMHE 65178).
Pfizer said it intends to seek expansion of the Zirabev label in the U.S. to include the treatment of epithelial ovarian, fallopian tube and primary peritoneal cancer as early as January 2021, pending regulatory approval.
The company has previously said it plans to launch Zirabev in Europe in June after Avastin patents expire (APMHE 65767).

Biosimilar Rituxan

Pfizer also said it has launched Ruxience, a biosimilar version of Roche's Rituxan (rituximab), in the U.S. on Thursday.
The drug has a wholesale acquisition cost of $71.68 per 10 mg, a 24% discount on the list price of the originator product.
Ruxience was approved in July last year for adults with non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (APMHE 63808).
Other approved biosimilar versions of rituximab include Celltrion/Teva's Truxima, which was authorised by the FDA in November 2018 (APMHE 60812).
Sandoz in 2018 abandoned its attempts at U.S. regulatory approval for a biosimilar of Rituxan after a rejection from the Food and Drug Administration (FDA) (APMHE 60438).
Rituxan, known as MabThera in some regions, is another big seller for Roche. For the first nine months of 2019 the company reported revenues of 3.39 billion Swiss francs (€3.17) in the U.S.
Rituxan/MabThera sales are on a sharp decline in Europe after the launch of biosimilar competition in 2017. Sales crashed 33% in the region to 470 million Swiss francs (€438 million) for the first nine months of 2019.

Biosimilar Herceptin

Pfizer also plans to launch Trazimera, a biosimilar version of Roche's Herceptin (trastuzumab) on 15 February.
It will have a wholesale acquisition cost of $80.74, a 22% discount on the list price of Herceptin.
Trazimera was approved in the U.S. in March last year for the treatment of human epidermal growth factor receptor 2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
There are several Herceptin biosimilars approved in the U.S., including versions of the drug from Amgen/Allergan, Celltrion/Teva, Samsung Bioepis and Mylan/Biocon (APMHE 63339, APMHE 61095, APMHE 61504, APMHE 55870).
Herceptin's U.S. sales were 2.17 billion Swiss francs (€2.03 billion) for the first nine months of 2019.
Pfizer's Trazimera was approved in Europe in 2018 (APMHE 59139). Like Rituxan/MabThera, Herceptin sales are crashing in Europe where the drug has been facing competition for longer. Revenues were down 44% for the first nine months of 2019 to 801 million Swiss francs (€747 million).

Roche puts faith in new drugs

For its part, Roche has previously said it is "increasingly confident" that it can overcome biosimilar erosion.
Bill Anderson, chief executive for the Swiss firms' pharma business, said in September last year that Roche has "the ability to absorb biosimilar losses and maintain growth" due to newer product sales, such as Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine) (APMHE 64388).



Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to the latest stories

Our coverage includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.


an initial 10 day temporary access of APM Health Europe.