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Market Access
Medicare Negotiated Drugs Can Face Immediate Generic, Biosimilar Substitution, CMS Proposal Confirms
Stelara, Xarelto, Januvia and Farxiga, which are expected to have biosimilar or generic competition before the end of 2026, could be the first negotiated drugs subject to the policy.
The UK market has become tougher for smaller innovators, says Andy Mears, CEO of Deltex Medical, which plans to launch a new iteration of its minimally invasive ultrasound-based technology, the oesophageal Doppler monitor. He explained how market access challenges have steepened.
At the 2025 J.P. Morgan Healthcare Conference, Johnson & Johnson outlined a new competition blueprint for anti-inflammatory biosimilars, going beyond the next blockbuster Tremfya.
Rounding up another important year in the fight against HIV, the MPP’s executive director Charles Gore speaks to Generics Bulletin about the organization’s biggest milestones in the past 12 months.
EU joint clinicals assessments introduced under the HTA Regulation have now gone live for cancer medicines and advanced therapies.
A draft royal decree would pave the way for more transparency in pricing and reimbursement decision-making processes and boost competition to increase the participation of generic medicines.
When federal chancellor Olaf Scholz lost his parliamentary vote of confidence in mid-December, it officially opened up the way for the elections the German leader had already penciled in for 23 February. The medtech industry has not been slow to set out its demands of the incoming government.
As application of the Health Technology Assessment Regulation nears, the European Commission has launched two new websites to help developers kick start the joint clinical assessment process and request a joint scientific consultation.
Teva vows to make two of its inhalers more accessible in the US through charity Direct Relief, despite still being tangled up in a lawsuit with Amneal over ProAir HFA. Also, another inhaler maker GSK is scrutinized over its pricey authorized generic alternative.
The EU-level joint clinical assessments that will be introduced under the Health Technology Assessment Regulation from January 2025 represent a huge shift for drug companies launching products in the EU. Industry experts Alexander Natz and Matias Olsen offer key advice to help companies prepare for what is to come.