For Inflectra launch, Pfizer uses ‘hybrid model’ to home in on HCPs
Pfizer hit the market with Inflectra, a biosimilar of Johnson & Johnson’s Remicade. And with the launch came not only the beginning of a new class of copycats, but a new way to go to market. Each biosimilar, even versions of the same biologic—while required to be “highly similar”—are technically different and come with different datasets and proof points. So, Pfizer went to work to create a new “hybrid model” to bring biosimilars to market. Through this model, each biosimilar brand launch will be customized, each will also leverage the scale of the model platform.
US FDA approves Rubraca to treat advanced ovarian cancer
The US Food and Drug Administration (FDA) has granted approval to Rubraca (rucaparib) for the treatment of advanced ovarian cancer in women. The poly ADP-ribose polymerase (PARP) inhibitor Rubraca is approved for women who have been treated with two or more chemotherapies and whose tumours have BRCA gene mutation as identified by a companion diagnostic test approved by the FDA. Involved with repairing damaged DNA, BRCA genes normally work to prevent tumour development. Mutations of these genes are expected to lead to certain cancers, including ovarian.Rubraca blocks an enzyme involved in repairing damaged DNA.
EMA approves MSD’s PD-1 therapy Keytruda to treat patients with NSCLC
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval of MSD’s Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC). Keytruda is an anti-programmed death-1 (PD-1) therapy that blocks the biological pathways cancers use to disguise themselves from the immune system. The drug has been recommended for patients with NSCLC whose tumours have high PD-L1 expression with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations.
Mylan launches authorized generic version of EpiPen
Mylan has launched the authorized generic version of EpiPen (epinephrine injection, USP) auto-injector, after the recent price hike criticism. The self-injectable device (auto-injector) contains epinephrine, the first-line treatment for life-threatening allergic reactions or anaphylaxis. Expected to reach pharmacies from next week, the authorized generic has the same drug formulation and device functionality as EpiPen auto-injector that is administered in the same way. The authorized generic for EpiPen is available in strengths of 0.15 mg and 0.3 mg.