Despite new pricing rules, France still offers opportunities for Early Access to Orphan drugs
Since March 2021, there have been some changes in the pricing of pharmaceuticals in France, leading progressively to a s...
08 September, 2022CarthaGenetics® focuses on Orphan Drugs and Advanced Therapies areas with unmet needs. Good health is vital to all of us, and finding sustainable access to innovative treatments is our motto. That’s why we are committed to providing patients and physicians with innovative drugs in development.
Early access programs in Europe: a regulatory tool with pre-marketing impact.
Read MoreTo be eligible for an EAP, your drug candidate must fulfill several criteria
Read MorePlanning for your managed access program should be considered as early as possible from Phase II trials onwards.
Read MoreEarly access programs in Europe: a regulatory tool with pre-marketing impact.
Read MoreTo be eligible for an EAP, your drug candidate must fulfill several criteria
Read MorePlanning for your managed access program should be considered as early as possible from Phase II trials onwards.
Read MoreDue to difference in legislation, EAPs to Orphan Drugs vary much across Europe.
Read MoreUsually, hospitals and/or national insurance, or insurances systems bear the costs of Named Patient Sales in most countries (France, Italy, Turkey, Switzerland and Spain).
Read MoreImplementation and management of your EAP requires significant knowledge, experience and resources. Your company may not have all the specific experience in this highly regulated environment nor the dedicated resources.
Read MoreDue to difference in legislation, EAPs to Orphan Drugs vary much across Europe.
Read MoreUsually, hospitals and/or national insurance, or insurances systems bear the costs of Named Patient Sales in most countries (France, Italy, Turkey, Switzerland and Spain).
Read MoreImplementation and management of your EAP requires significant knowledge, experience and resources. Your company may not have all the specific experience in this highly regulated environment nor the dedicated resources.
Read More
• For a rare lysosomal disorder, CarthaGenetics® has been able to obtain clinical approvals in 2 months in Turkey with a strong collaboration with the global CRO picked up by our customer.
• Due to its network, CarthaGenetics® found for another ultra rare disorder 58 patients in one country, where a big pharma with a competitive treatment and many sales reps in the field has only identified 5 !
• For another Ultra rare disorder, CarthaGenetics® helped some European patients relocation in the US for the duration of a phase III in the USA.
Biosimilars are copies of approved innovator biotherapeutic products that have been demonstrated to be comparable to the corresponding original product in terms of quality, safety and efficacy. They offer improved affordability since they come on the market at a significantly reduced price compared to the original product.
For Orphan Drugs, despite the specific « enlarged » patent protection given by Orphan Drug status, biosimilars constitute the beginning of a brand new era, by fostering access to all patients in need, especially in emerging countries.
Biosimilars are copies of approved innovator biotherapeutic products that have been demonstrated to be comparable to the corresponding original product in terms of quality, safety and efficacy. They offer improved affordability since they come on the market at a significantly reduced price compared to the original product.
For Orphan Drugs, despite the specific « enlarged » patent protection given by Orphan Drug status, biosimilars constitute the beginning of a brand new era, by fostering access to all patients in need, especially in emerging countries.
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Since March 2021, there have been some changes in the pricing of pharmaceuticals in France, leading progressively to a s...
08 September, 2022CarthaGenetics is attending the SSIEM congress (Scientific Society for Inborn Errors of Metabolism) in Freiburg in Breis...
31 August, 2022For patients with rare diseases, time to access has been always the greatest challenge....
09 August, 2022We have worked for international biopharmaceutical companies from around the world who wish to start clinical trials and/or commercial operations (prelaunch and Early Access Program) in Europe (incl. Turkey) & North Africa.