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House Subcommittee Holds Fiery Hearing on Generic Competition
On Wednesday, March 13, 2019, the House Energy and Commerce Subcommittee on Health held a hearing to discuss a slate of bills, all…
January MedPAC Recommendations: Rebates & Biosimilars
The Medicare Payment Advisory Commission (MedPAC), responsible for advising Congress on Medicare issues, held its January 2019…
New Law Requires Biosimilar Deals to be Submitted to the FTC
On October 10, 2018, United States President Donald Trump signed a bill into law that requires drug makers to send details of…
FDA Holds Public Meeting on Biosimilar Action Plan
On September 4, 2018, the United States Food and Drug Administration (FDA) held a public meeting to gather stakeholder input on…
Biosimilars Rapidly Gain Market Share in EU
As reported by Regulatory Focus, Biosimilar experts from across the EU continue to show how rapidly biosimilars have gained market…
MedPAC Proposes Changes to Medicare Part D for Biosimilars
In mid-January 2018, the Medicare Payment Advisory Commission (MedPAC) met to discuss Medicare payment adequacy and vote on 2019…
FDA Approves Sixth United States Biosimilar
Recently, the FDA announced that it approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s…
Biotechnology Investors Beware?
One thing the pharmaceutical stock industry has seen over many decades is price sensitivity to small statements and comments made…
FDA Finalizes Guidance on Assigning Non-Proprietary Names to Biologics and…
Recently, the Food and Drug Administration (FDA) finalized guidance detailing its approach to assigning non-proprietary names to…
2017 Biosimilar Update
We have taken an interest in the growing biosimilars market in the United States. Recently, we covered the Friends of Cancer…