On 11^th March 2019, Pfizer Inc announced the FDA had approved Trazimera (trastuzumab-qyyp), a biosimilar to Roche’s Herceptin (trastuzumab) for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Amrita Gujral, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the impact of this recent biosimilar approval on the market:

“HER2-positive cancers are often linked to poor prognosis so the introduction of this biosimilar will allow for more affordable access to targeted therapies helping to improve overall survival for this subset of patients. 

“However Pfizer will need to work hard to address negative patient perception as many newly diagnosed patients need further assistance in understanding biosimilars and how they work in terms of efficacy and safety, before making an informed consent about receiving them. Patients who are already receiving treatment with Herceptin, may be hesitant to change as currently there is no standardized international global substitution policy in place.

“Trazimera is Pfizer’s first oncology biosimilar to be approved by the FDA; however it is Pfizer’s fifth biosimilar to gain FDA approval. Pfizer is taking a very active approach in developing biosimilars in comparison to Roche, who will not look to develop other biosimilars of their own branded products such as Herceptin.

“Despite Herceptin being one of Roche’s most profitable drugs, bringing in sales of $6.98 billion in 2018, the company has already started to experience a reduction in sales due to rising competition from biosimilars, particularly in Europe and Japan where a 16% reduction in Herceptin sales was seen in 2018. Roche believes that biosimilar erosion will be lower in the US than in Europe; however this assumption could be affected if the Trump administration chooses to work to lower drug prices as a top priority in 2019.

“Over the next five years, this Roche’s decision will undoubtedly lead to there being changes in the total sales of HER2 targeted drugs within their oncology portfolio, however, the company may see the loss in Herceptin sales being replaced by increased sales from their newer biologic drugs such as Perjeta and Kadcyla.”