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German Law Introducing Biosimilar Substitution Could Lead To Tendering

 
• By Francesca Bruce

A new law in Germany could lead to tendering in the biosimilars space.

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A new law will introduce biosimilar substitution and could lead to tendering • Source: Shutterstock

A controversial new law that introduces biosimilar substitution in Germany is due to come into force in the next few weeks. The provisions will likely lead to tendering, which would be the wrong approach to increasing biosimilar penetration, according to Alexander Natz, secretary general of EUCOPE, the European Confederation of Pharmaceutical Entrepreneurs.

The Act for Greater Security in the Pharmaceutical Supply System, known locally as GSAV, passed through both houses of parliament,...

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More from Europe

Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 
• By Francesca Bruce

Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

 
• By Vibha Sharma

The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.

New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Why Chiesi’s Raxone Faced A Decade-Long Wait For English Funding

 
• By Eliza Slawther

Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.

More from Geography

New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.