US pharma giant Pfizer confirmed on 15 January 2019 that it had terminated five of its preclinical biosimilar programmes after looking at the results of the company’s annual investment review.
Pfizer’s news comes as the latest in a series of announcements from companies abandoning biosimilars. In September 2017, Germany-based Merck KGaA sold its biosimilars business to Fresenius Kabi [1]. In November 2018, Boehringer Ingelheim and Sandoz announced that they were abandoning parts of their biosimilar programmes [2], whilst Pfizer had reached a settlement with AbbVie that will delay US market access until 2023 [3].
A Pfizer representative indicated that the decision was in part due to the renewed focus on the company’s late-stage assets as the biosimilars would not have been available to patients ‘for at least 4 to 8 years’. Despite the decision, Pfizer says that it remains committed to biosimilars and does not plan on exiting the biosimilars market. The company has four biosimilars approved in the US [Inflectra (infliximab-dyyb), Ixifi (infliximab-qbtx), Nivestym (filgrastim-aafi) and Retacrit (epoetin alfa- epbx)] and three in Europe [Nivestim (filgrastim), Trazimera (trastuzumab) and Zirabev (bevacizumab)]. The company also has five other candidate biosimilars in mid- to late-stage development.
Pfizer’s trastuzumab biosimilar (PF 05280014) referencing Herceptin is in registration phase; and will continue to develop the following biosimilar products: 1) rituximab biosimilar (PF 05280586) referencing Rituxan; 2) adalimumab biosimilar (PF 06410293) referencing Humira; 3) bevacizumab biosimilar (PF 06439535) referencing Avastin; and 4) pegfilgrastim biosimilar (PF 06881894) referencing Neulasta, see table 1.
| Table 1: Pfizer’s biosimilars approved or in development
|
| Compound name
|
Mechanism of Action
|
Indication
|
Phase
|
| PF-05280014, a potential biosimilar to Herceptin® (trastuzumab)
|
erbB2 TK inhibitor
|
Metastatic breast cancer (biosimilar)
|
Registration
|
| PF-05280586, a potential biosimilar to Rituxan®/ MabThera® (rituximab)
|
CD20 antigen antagonist
|
Follicular lymphoma (biosimilar)
|
Phase III
|
| PF-06410293, a potential biosimilar to Humira® (adalimumab)
|
Tumour necrosis factor inhibitor
|
Rheumatoid arthritis (biosimilar)
|
Phase III
|
| PF-06439535, a potential biosimilar to Avastin® (bevacizumab)
|
VEGF inhibitor
|
Non-small cell lung cancer (biosimilar)
|
Phase III
|
| PF-06881894, a potential biosimilar to Neulasta® (Pegfilgrastim)
|
Human granulocyte colony- stimulating factor
|
Neutropenia in patients undergoing cancer chemotherapy (Biosimilar)
|
Phase I
|
| VEGF: vascular endothelial growth factor. Source: Pfizer
|
The cuts to Pfizer’s biosimilar programme will be implemented by July 2019.The cuts will also result in the loss of 150 jobs in Lake Forest, Illinois, USA and in Chennai, India and come as part of the Hospira acquisition three years ago [4].
Related article
Positive phase III results for Pfizer’s trastuzumab biosimilar
References
1. GaBI Online - Generics and Biosimilars Initiative. Fresenius Kabi acquires Merck KGaA’s biosimilars business [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from: www.gabionline.net/Pharma-News/Fresenius-Kabi-acquires-Merck-KGaA-s-biosimilars-business
2. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim and Sandoz abandon biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from: www.gabionline.net/Biosimilars/General/Boehringer-Ingelheim-and-Sandoz-abandon-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. AbbVie makes more deals delaying adalimumab biosimilars in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from: www.gabionline.net/Pharma-News/AbbVie-makes-more-deals-delaying-adalimumab-biosimilars-in-US
4. GaBI Online - Generics and Biosimilars Initiative. Pfizer cuts some biosimilars after Hospira deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 1]. Available from: www.gabionline.net/Pharma-News/Pfizer-cuts-some-biosimilars-after-Hospira-deal
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