July 9, 2016 09:13 AM EDTUpdated July 10, 02:21 PM

Why we need to lower U.S. regulatory barriers around biosimilar approvals now

The FDA’s internal review on Amgen’s biosimilar of Humira reads like a product endorsement. Posted on Friday, the agency insiders essentially said: Let’s give it …

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Why we need to lower U.S. regulatory barriers around biosimilar approvals now

This article is available only to Premium subscribers

PTC reports Phase 2 ALS fail, sells priority review voucher for $150M

Novartis to cut 139 jobs in NJ as part of commercial refocus

Applied Therapeutics' rare disease drug gets a CRL

Advanz Pharma faces revocation of European authorization for liver disease drug Ocaliva

FDA is looking into hematology risks after patients take Bluebird's Skysona gene therapy

Bristol Myers sues the federal government over 340B, following other drugmakers

Why we need to low­er U.S. reg­u­la­to­ry bar­ri­ers around biosim­i­lar ap­provals now

This article is available only to Premium subscribers

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Why we need to lower U.S. regulatory barriers around biosimilar approvals now

PTC reports Phase 2 ALS fail, sells priority review voucher for $150M

Novartis to cut 139 jobs in NJ as part of commercial refocus

Applied Therapeutics' rare disease drug gets a CRL

Advanz Pharma faces revocation of European authorization for liver disease drug Ocaliva

FDA is looking into hematology risks after patients take Bluebird's Skysona gene therapy

Bristol Myers sues the federal government over 340B, following other drugmakers