GMP News, GMP guidelines, GMP Violations, GMP warnings A Public Health Global News Portal

Welcome to gmpviolations.com FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters..

150000+ Industry Leaders already read it everyday

Tuesday, August 23, 2016

Now, Roche takes Zydus Cadila to court over breast cancer drug published @ news gmpviolations.com

The petition states the approval of Cadila’s drug as a biosimilar has caused Roche “irreparable damage” in violation of applicable law for testing and approval of biosimilar drugs.

NEW DELHI: Swiss biotech giant Roche has sued Ahmedabad-based Zydus Cadila and India's central drug regulator at the Delhi High Court over the approval and launch of breast cancer drug Vivitra (trastuzumab). Roche is planning to block the product from the market.

Roche, according to the petition, has taken objection over the approval and launch of a purported biosimilar version of its own trastuzumab without adequate tests in line with the provisions of the country's Drugs and Cosmetics Act as well as the biosimilar guidelines. Biosimilars are copies of complex biotech drugs.

The petition states the approval of Cadila's drug as a biosimilar has caused Roche "irreparable damage" in violation of applicable law for testing and approval of biosimilar drugs.

Roche declined to comment on the subject while Cadila did not respond to ET's queries.

Cadila launched Vivitra in January this year, joining Biocon and Mylan, which had launched their own copies of trastuzumab in 2014.

Cadila had already filed a petition in the Bombay High Court in anticipation of an injunction from Roche after the Swiss company took Biocon, Mylan and Reliance Lifesciences to court.

Roche and its Indian partner, Emcure, market trastuzumab as Herclon or Biceltis in India.

In an earlier decision, the Delhi High Court had directed Biocon and Mylan to make label changes and market their drugs without ascribing biosimilarity to Roche's trastuzmab brands.

Published by: News
Source: ETHealthworld

www.gmpviolations.com
Share:

0 comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...

AMAZON BEST DEALS

Popular Posts

AMAZON BEST DEALS

Subscribe Free GMP Guidelines

Enter your email address:

Delivered by FeedBurner

Followers

Printfriendly

Subscribe via email for free

Services

Enter your email address:

Delivered by FeedBurner

Contact Form

Name

Email *

Message *

Menu :
Powered by Blogger.

Visitors

    Translater

    Related Posts Plugin for WordPress, Blogger...

    Category

    2016 (37) 2017 (85) 2018 (9) 211 CFR (1) 211.63 (1) 483 (5) AAFA (1) Abbott (2) AboutUs (1) ALCOA (1) Alerts (2) ANDA (1) Anshu (2) Antibiotics (1) apic (1) APR17 (8) APS (2) Articles (4) AstraZeneca (1) Aug17 (2) Aurobindo (2) Author (2) Authors (8) Biocon (1) cadila (1) capa (3) CDSCO (5) Change control (1) Christian Green (1) cipla (2) Cleaning validation (1) Data Integrity (9) dec16 (15) Definations (1) Deviations (1) Donald Trump’s (2) Downloads (17) Dr.Reddy's (4) eca (1) EIR (1) Eli Lilly (1) ema (12) EU (9) FDA (70) FDA Guide (18) FEB17 (15) Genaral (1) General Health (2) GMP (1) GMP News (36) gsk (2) GuidelineEU (10) GuidelinesG (5) GuidelineW (2) GV/0117/001 (1) GVAuthors (3) Health (4) HOSPIRA (1) ICH (3) ICHGuide (3) import alert (1) India (1) ISPE (1) James Bullock (1) JAN17 (23) Jul17 (8) July17 (1) Jun17 (4) Lupin (2) Mahender (39) MAR17 (13) Mar18 (7) May17 (10) MHRA (3) MHRA guide (1) Mumbai (1) Mylan (4) Natco (1) News (55) Non Complinaces (1) Nov16 (5) Novartis (1) oct (1) Oct16 (10) OCT17 (1) PDA (1) Personnel (1) pfizer (1) pics (8) Picsguide (2) QbD (1) Quality Docs (1) RCA (1) Recall (1) safety (1) Sanjeev Kumar Singh (4) Sanofi (1) Sep16 (6) Siegfried Schmitt (2) SUN (1) TGA (3) TOP 10 PHARMA (1) USP (2) Validation (3) Warning Letters (43) WHO (6) zika (1)

    Sponsors

    Theme Support