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FDA Grants Interchangeable Designation to Pfizer’s Biosimilar ABRILADA™

NEW YORK, October 5, 2023 – Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The interchangeable designation applies to all approved indications of ABRILADA, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.

Hospira, Inc. Issues A Voluntary Nationwide Recall For 4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection, USP Due To The Potential For Presence of Glass Particulate Matter

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FOR IMMEDIATE RELEASE - October 2, 2023 - NEW YORK, NY.,

Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10mL vial; 1% Lidocaine HCl Injection, USP, 50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level. The recall was initiated due to the potential for presence of glass particulate matter. 

Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate

  • Strong immune response shown in both children and adolescents one month after booster dose (month 19) in VLA15-221 study
  • Previously observed high anamnestic antibody response in adults confirmed
  • VLA15 well-tolerated in all age groups following booster dose

Pfizer Receives Positive CHMP Opinion for Alopecia Areata Treatment

New York, July 21, 2023 — Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for LITFULO™ (ritlecitinib), an oral treatment, recommending marketing authorization of once-daily 50 mg for individuals 12 years of age and older with severe alopecia areata.

Pfizer Receives Positive CHMP Opinion for RSV Vaccine Candidate to Help Protect Infants through Maternal Immunization and Older Adults

•    Pfizer’s RSV vaccine candidate, RSVpreF, would help address substantial burden of RSV disease in individuals 60 years of age and older and in infants from birth through six months of age
•    If approved, Pfizer’s RSV vaccine candidate would be first and only vaccine for both older adults and administration to pregnant individuals to help protect their infants 

Pfizer and the European Commission Enter into Manufacturing Reservation Agreement for mRNA-based Vaccines to Help Protect Against Future Pandemics

NEW YORK, June 30, 2023 — Pfizer Inc. (NYSE: PFE) announced today that it has entered into a manufacturing capacity reservation agreement with the European Health and Digital Executive Agency (HaDEA) of the European Commission (EC), which provides the European Union (EU) access to doses of a mRNA-based vaccine should one be developed to protect against a future pandemic-causing disease.

Pfizer and BioNTech Submit Applications to U.S. FDA for Omicron XBB.1.5-Adapted Monovalent COVID-19 Vaccine

  • The submissions reflect guidance from FDA and other major health authorities to provide COVID-19 vaccines better matched to currently circulating sublineages
  • The companies expect to be ready to ship the adapted vaccines immediately following regulatory authorization/approval

NEW YORK and MAINZ, GERMANY, JUNE 23, 2023 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have submitted regulatory applications to the U.S.

Pfizer and BioNTech Initiate Application to European Medicines Agency for Omicron XBB.1.5-Adapted Monovalent COVID-19 Vaccine

  • The application reflects guidance from EMA and other major health authorities to provide COVID-19 vaccines better matched to currently circulating sublineages
  • The companies expect to be ready to ship the adapted vaccines to EU member states immediately following regulatory approval  
  • Application in the U.S. expected to follow in the coming days

NEW YORK and MAINZ, GERMANY, JUNE 23, 2023 — Pfizer Inc.

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