thuốc sinh học tương đương trong thấp khớp học

nucleotide trong gene... So Etanercept-szzs GP2015Etanercept-szzs Erelzi, Sandoz... So Etanercept-szzs GP2015Griffiths CEM et al.. 2017Etanercept-szzs Erelzi, Sandoz... Infliximab Biosim

Trong

Minh , Ph.D.

,

sinh

sinh

Quy Sinh

Gene

SX trong

Bioreactors

Mellstedt H et al Ann Oncol 2008

tinh

Research

Drug Discovery

Pre-clinical Study

Clinical Trials Phase II Phase III

10,000

Candidates

250

Candidates

5

Candidates

1 Drug Risk

Post-marketing Study

https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html

nucleotide trong gene

Quy

quy (1 liter) sang quy (500 - 5000 liters)

Quy tinh ,

( amino acid

)

nhau

(phase 3) (phase 2)

(phase 2)

(phase 1)

Sinh

Sinh

Kay J SPARTAN 2018

Biosimilar regulatory

framework

implementation

EU: 2005

U.S.: 2009 (BPCI)

BPCI: Biologics Price Competition and Innovation Act

So Sinh

So Etanercept-szzs (GP2015)

Etanercept-szzs (Erelzi, Sandoz)

So Etanercept-szzs (GP2015)

Griffiths CEM et al et al Br J Dermatol 2017

Etanercept-szzs (Erelzi, Sandoz)

Infliximab Biosimilars Cho

Kay J SPARTAN 2018

Remsima: Celltrion

So &

Sinh

Kay J SPARTAN 2018

Infliximab-abda: Renflexis, MERCK

Infliximab-dyyb 2017

Inflectra: Infliximab-dyyb, Pfizer

Hakim A JAMA 2017

Ty

(

Biosimilars ro

50%

50% Biosimilars

an

C m n !