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- PMLiVE

Reig Jofre

- PMLiVE

EMA on track with biosimilars guidance says industry

Updates expected to build confidence among healthcare professionals and patients

Novartis building

Novartis weighs in on biosimilar naming debate

Files petition urging FDA to keep system where biosimilars share a name with the original drug

Sanofi reception

EASD 2013: Sanofi prepared for biosimilar threat to Lantus

Next generation insulin U300 set to launch at time of patent expiration

- PMLiVE

Generics industry pressures FDA over biosimilar naming standards

GPhA says biosimilars should carry same name as branded biologic medicines

EU flag

First biosimilar mAb gets the nod in EU

Approval for Hospira's version of J&J's Remicade has global implications

- PMLiVE

Baxter taps Coherus for Enbrel biosimilar

Deal to develop copy of Amgen and Pfizer's arthritis and psoriasis is worth up to $246m

- PMLiVE

Boehringer’s first cancer drug leads EMA recommendations

Afatinib recommended for lung cancer under brand name Giotrif

- PMLiVE

Lonza ends biosimilars deal with Teva

Chemical firm cuts losses after four-year development deal

- PMLiVE

Lilly/ Boehringer’s Lantus biosimilar accepted for EMA review

Moves pharma companies’ version of Sanofi's blockbuster insulin a step closer to approval

- PMLiVE

First mAb biosimilars set for European approval

Celltrion and Hospira's versions of J&J's blockbuster Remicade recommended by CHMP

- PMLiVE

Sandoz takes short route for biosimilar Enbrel approval

Novartis subsidiary initiates late-stage trial to support use in chronic plaque-type psoriasis

- PMLiVE

EMA seeks comment on final biosimilar guidance

Outlines thinking on non-clinical and clinical development requirements

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