Biosimilar Antibody-Drug Conjugates? Pfizer Isn’t Banking On It

‘The Regulatory Path Has To Be Determined. It Doesn’t Exist Today’

Pfizer’s $43bn agreement to acquire Seagen would layer its portfolio and pipeline with vastly complex antibody-drug conjugates – a class of drug that execs feel might be almost immune to biosimilar competition. Generic firms’ history of frustration with ADCs suggests they may be right.

NEW YORK, NEW YORK - DECEMBER 05: CEO of Pfizer Inc. Albert Bourla, DVM, Ph.D. attends 2019 Forbes Healthcare Summit at the Jazz at Lincoln Center on December 05, 2019 in New York City. (Photo by Steven Ferdman/Getty Images)
• Source: Steven Ferdman/Getty Images (Steven Ferdman/Getty Images)

Pfizer Inc.’s recent determination to pay $43bn for antibody-drug conjugate (ADC) pioneer Seagen Inc., the largest pharmaceutical deal since AbbVie Inc.’s $63bn takeover of Allergan plc three years ago, stems in part from the remote chance that a biosimilar sponsor would ever be motivated – or indeed able – to replicate the groundbreaking medicines.

More from Biosimilars

Stelara Biosimilars Storm US Market With 85% Discounts Ahead Of Price Drop In Medicare

 
• By 

The development could highlight the power of competitive market forces over government price controls or suggest Medicare price negotiation is enhancing competitive market forces.

Belgian Body Hits Out At Roche For Delaying Biosimilar Competition

 
• By 

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

US FDA May Be Shifting Its Thinking On Biosimilar Trials

 
• By 

Two recent disclosures from Xbrane Biopharma and Formycon demonstrate the evolving US Food and Drug Administration thinking about the need for Phase III trials to support biosimilar filings.

Global Regulators Consider Extending Pilot On Post-Approval CMC Changes After Positive Findings

 

Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.

More from Biosimilars & Generics