Unacom Pharma News

Mon 4th February- Fri 8th February

Monday 4th February 2019

European decision on biosimilar change causes dismay for the Industry

The European parliament voted in favour for allowing manufacturers to produce and stockpile generic and biosimilar medicine, two years before the original brands exclusivity ends. The proposed change could come in as soon as 2021 and it involves adding a new ‘manufacturing waiver’ to the SPC (Supplementary Protection Certificate), a current law which extends market exclusivity for branded medicines in the EU. The waiver is being introduced because generic and biosimilar companies in Europe are restricted by strict rules which prevent them from manufacturing their copies before the SPC expires. Competitors in China, Canada and India face no such restriction and can be ready to release their versions on ‘Day 1’ of the exclusivity ending. The new waiver will create a more level playing Field for European Biosimilar firms.
The usual patent for a pharma product in the EU is 20 years, but an SPC can extend this up to 5 years, considering the time taken to put in through development and regulatory approval. Currently biosimilar manufacturers cannot manufacture their copycat products during the SPC period. The proposed changes mean that these companies will be able to produce generics for export outside the EU, during this period and stockpile products so they can launch in the EU market, as soon as exclusivity ends.
European generic manufacturers have long argued that international companies face an unfair advantage as they are not restricted by these rules. The EC also believe that these changes will boost the EU competitiveness, as a hub for R&D.

Tuesday 5th February 2019
Global pharma market heading for future downturn says IQVIA
The global pharma market is set to be headed for a downturn between now and 2023, as growth rates dip below the 6% average seen in the last five years. Growth will range from 3% to 6% in the next coming years, due to sluggish growth in Europe and static/shrinking sales in Japan. China’s wider economic slowdown will also affect pharma, as pharmerging markets will see lower growth in the five years compared to the five years past, as the economic growth and healthcare access expansions of the past contribute less to growth.
IQVIA, is predicting ‘explosive’ growth in biosimilars, which will result in $160bn in lower spending over the next five years, with 18 of the top 20 drugs facing biosimilar competition by 2023. There is also an expected increase in the output of novel products from industry pipelines, with the average yearly number of new novel products released expected to rise from 45 to 54 by 2023. With the increasing number of launches, shifting towards specialty products such as oncology products.

Wednesday 6th February
GSK signs $4.2bn immunotherapy deal with Merck
Merck and GSK have unveiled a global alliance to jointly develop and commercialize M7824, a novel immunotherapy with potential to treat a wide range of cancers This drug is just one of eight immune-oncology studies ongoing or expected to begin in 2019, with GSK hoping to make up for lost time and enter the hotly anticipated Immuno-oncology field.
The deal with GSK, sees Merck receive an upfront payment of 300million Euros with potential development milestones payments of up to 500 million euros, triggered by data from the M7824 lung programme. With this added to future approval and commercial milestones of up to 2.9bn euros. The total potential deal value comes to $4.2bn
GSK is likely to have outbid other interested parties, with Pfizer being the most likely candidate, due to its existing alliance with Merck in Immuno Oncology.
GSK and Merck will jointly conduct development and commercialization with all profits and costs from the collaboration being equally shared on a global basis.

Thursday 7th February 2019
UK unveils new antibiotic buying plan, to combat rising antimicrobial resistance
Health secretary Matt Hancock has revealed the UKs five year plan to handle rising antibiotic resistance. Key elements of the plan include incentives for pharmaceutical industries to carry out R&D in new antimicrobial drugs, such as the £50 million in funding made available via the UKs GlobalAMR Innovation Fund, reducing the inappropriate usage of antibiotics by 15% in five years. The plan also set out specific targets, including halving healthcare associated Gram-negative blood stream infections, reducing the overall number of specific drug resistant infections by 10% within five years and reducing antibiotic use in food producing animals by 25% between 2016 and 2020.  

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