Av
Den europeiska läkemedelsmyndigheten Ema släppte i fredags förslag på nya riktlinjer för hur kopior av biologiska läkemedel, även kallade biosimilars, ska hanteras. De nya riktlinjerna innefattar kopior på interferon beta-baserade läkemedel mot multipel skleros, ms.
I dag finns flera biologiska MS-läkemedel på marknaden som innehåller interferon beta, bland annat Mercks Rebif och Biogen Idecs Avonex. Men eftersom patenten är på väg att gå ut har Ema tagit fram riktlinjer för vilka prövningar som behöver göras för att få kopior godkända. Biologiska läkemedel skiljer sig från läkemedel som består av en enkel kemisk molekyl eftersom det inte går att garantera att kopian blir exakt samma som originalet. Inför varje ny grupp av biologiska läkemedel som är på väg att ha utgående patent tar Ema fram nya riktlinjer specifika för just den läkemedelsgruppen. Sedan tidigare finns riktlinjer för till exempel insulin och sompatropin. Senare i vår väntas nya riktlinjer för monoklonala antikroppar.
Förslaget på riktlinjer för interferon beta är nu presenterad och läkemedelsverket kommer nu att se över eventuella synpunkter för att sedan ta beslut i mars eller april.
I dag finns flera biologiska MS-läkemedel på marknaden som innehåller interferon beta, bland annat Mercks Rebif och Biogen Idecs Avonex. Men eftersom patenten är på väg att gå ut har Ema tagit fram riktlinjer för vilka prövningar som behöver göras för att få kopior godkända. Biologiska läkemedel skiljer sig från läkemedel som består av en enkel kemisk molekyl eftersom det inte går att garantera att kopian blir exakt samma som originalet. Inför varje ny grupp av biologiska läkemedel som är på väg att ha utgående patent tar Ema fram nya riktlinjer specifika för just den läkemedelsgruppen. Sedan tidigare finns riktlinjer för till exempel insulin och sompatropin. Senare i vår väntas nya riktlinjer för monoklonala antikroppar.
Förslaget på riktlinjer för interferon beta är nu presenterad och läkemedelsverket kommer nu att se över eventuella synpunkter för att sedan ta beslut i mars eller april.
"Mercodia has been a supplier of reliable assays since 1991" 
"Medivir is a specialty pharmaceutical company with unique positioning on the Nordic market and our goal is become a profitable company in high growth" 
"To supply Swedish and Danish laboratories with laboratory equipment and furniture of highest quality and offer service on all delivered products." 
"Allenex is a life science company that develops, manufactures, markets and sells high quality products for the transplantation market." 
"To be acknowledged as the Best-in-Class provider of pharmaceutical development and manufacturing services by customers, employees & other stakeholders" 
"We turn medical research into applications for better health and well-being." 
"To develop innovative and effective pharmaceuticals within autoimmune/ inflammatory diseases and cancer where major medical need exists" 
"Our goal is to invest in innovations and develop new unique pharmaceuticals" 
"Our vision is to become one of the top 10 global providers of scientific instruments; we will get there by striving for market leadership in our respective product and application niches."
" 
"Uppsala BIO is a life science pathfinder. We build ways to make life science flourish, in cooperation with industry, academia, society and healthcare." 
"Innovation takes place when biology meets engineering; ICT is an enabler to solve the needs for increased functionality and reduced cost in Life Science" 
"APL provides high-quality services to Life Science. We are a Dedicated Partner from Discovery to Market." 
"Our services in ligand-based and structure-based drug design is a cost-efficient alternative for smaller pharmaceutical companies" 
"Our organisation value is to contribute to positioning Scandinavian healthcare and research in absolute world class." 
"Your work is important to us, we are committed to your success.
Innovative tools? Please download the Promega app." 
"We help our clients create significant business value through scientific expertise." 
"Dilafor is developing new products in the field of obstetrics, to provide an effective solution to the challenge of dystocia or protracted labor"
" 
"With our first class products and our committed and skilled colleagues we guarantee our customers the best support in the market, at no extra charge." 
"We are making it more attractive for companies to invest in innovation with reduced corporation tax on profits from patents to 10%." 
"PCG - a professional full service CRO for your clinical trials.
Powered by Viedoc, globally trusted eCRF, keeping trials within budget and timelines" 
"We are recognized as a flexible partner with short decision and lead times plus a proven record for the highest quality and cost efficiency." 
"Anton Paar is a product and service leader in the field of scientific instruments. We deliver uncompromised quality in everything we do." 
"Best in class companies see the value of optimising their business by having an effective strategy for information management and documentation." 
"We are entirely devoted to luminescence technology." 
"As a full service CRO with offices in all Nordic countries we can provide our customer with professional support throughout the clinical research." 
"Novel products for CVD treatment and prevention." 
"Our products enable an increased number of transplants leading to substantial cost savings for society and increased quality of life for patients." 
"We aim to be the pioneering benchmark in user-friendly software experience in combination with the highest level of quality." 
"We have a unique technological platform, built around 5HT-receptor antagonism, for the treatment of inflammation and pain"." 
"Discover your possibilities in one of Europe´s most productive life science regions. Welcome to Stockholm-Uppsala."
" 
"Together with Zacco our clients achieve their business goals through the management of their intellectual property." 
"Our reliability, customer service, global network and integrated technology make World Courier service truly "A service no one else can deliver"." 
"We offer effective staffing solutions provided by specialists, we understand a company’s specific needs and we know where to find the best talent." 
"The PolyPeptide Group is a world class manufacturer of peptide active pharmaceutical ingredients." 
"VWR is a global laboratory distributor of chemicals, life science products, consumables, equipment, instruments, furniture, e-commerce and services" 
"To adapt Competent Authorities´ requirements into opportunities is not just an artform - today it´s a business necessity." 
"Your global partner of pharmaceutical service and cGMP manufacturing" 
"To be the most attractive node and business platform in the Nordic countries for new and innovative Life Science companies" 
"TFS is today the leading European development partner for biopharmaceutical companies in their global clinical development process." 
"We promise to go the extra mile every day to ensure you receive the highest level of service and value with each shipment you entrust to us." 
"To become an internationally leading dental company with innovative, proprietary products of high therapeutic and commercial value." 
"Our aim is to be the best drug development partner to the biotechnology and pharmaceutical industry no matter where you are based." 
