PearceIP Blog

Read our latest updates & insights

Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.

Remicade™ Biosimilars US: Pfizer sues J&J for anticompetitive conduct

By Naomi Pearce | Sep 21, 2017

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Biosimilar development is not for the faint hearted. The time and costs involved in R&D, clinical, and regulatory are exorbitant, and the patent barriers to launch are unpreced...
Samsung receives approval to launch AmAb in South Korea

By Bioblast Editor | Sep 20, 2017

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Samsung says it has approval to sell biosimilar adalimumab in South Korea, but will delay launch due to patent expiry.
Samsung approved to commence Phase III clinical trials

By Bioblast Editor | Sep 20, 2017

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Samsung is approved by the Ministry of Food and Drug Safety in South Korea to commence Phase III clinical trials for biosimilar ranibizumab.
Samsung Bioepis receives positive CHMP opinion on Ontruzant®

By Bioblast Editor | Sep 15, 2017

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Samsung Bioepis announces it has received positive CHMP opinion on Ontruzant®, biosimilar trastuzumab for early breast cancer, metastatic breast cancer and metastatic gastric cancer. This is the first biosimilar trastuzumab recommended for EU approval.
CHMP gives positive approval for Boehringer Ingelheim's AmAb

By Bioblast Editor | Sep 15, 2017

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BI receives positive CHMP opinon on Cyltezo®, biosimilar to adalimumab. Approval is expected in Q4/17.
First wave of patent reform in AU: consultation period ends 17 Nov 2017

By Naomi Pearce | Sep 14, 2017

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IP Australia is inviting submissions by 17 November 2017 on the first wave of IP reform initiatives arising from the Government’s response to the Productivity Commission Repor...
Amgen/Allergan's bevacizumab Mvasti® approved in the US

By Bioblast Editor | Sep 14, 2017

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Amgen/Allergan’s bevacizumab biosimilar (Mvasti®) (bevacizumab-awwb) approved in the US for colorectal, lung, brain, kidney and cervical cancer. Read more
Sandoz announces 51 week results for AmAb biosimilar

By Bioblast Editor | Sep 14, 2017

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Sandoz announces at the EADV results from 51 week clinical study confirming that Sandoz’s biosimilar adalimumab matches Humira® in safety and efficacy profile.
Medicines for Europe Issues 2017 Biosimilar Market Review

By Naomi Pearce | Sep 13, 2017

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Eleven years after the launch of the first biosimilar product in EU, we are now in a position to calibrate our biosimilar market expectations with market experience, rather than ext...
Lupin secures external funding for etanercept program

By Bioblast Editor | Sep 13, 2017

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Lupin secures external funding for its etanercept biosimilars program.