Datamonitor Healthcare attended the ISPOR 21st Annual European Congress held in Barcelona on 10–14 November. Here, we present some of the hot topics discussed at the event.
This analysis includes insights from eight interviewed experts from pharma, medical device, or digital health companies.
The challenges faced by biosimilar developers are not unlike those confronting their branded counterparts. First, companies must develop high-quality biosimilars and obtain regulatory approval. Next, they must then navigate the vast array of commercial nuances that exist at the national level in order for their products to be used in the clinical setting.
As a supplement to our well-known quarterly Outlook report, Biomedtracker is pleased to present a longer-term look at some key late-stage drugs projected to hit the market in 2020.
The 71st Annual Meeting of the American Academy of Neurology (AAN) was held in Philadelphia, Pennsylvania, from May 4-10, 2019.
The 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) was held in Chicago, IL from May 31st through June 4th, 2019. This year’s conference was highly varied, with key data presented for drugs in numerous different classes and indications.
Faced with pressure from stakeholders – particularly patients – governments, regulators, and some countries have introduced new options and/or processes to speed up access to medicines. This includes access before marketing authorization, and speeding up the marketing authorization, or less often, the health technology assessment processes.
The American Diabetes Association (ADA) 79th Scientific Sessions was held in San Francisco, CA from 7–11 June 2019.
The first antibody-drug conjugate (ADC), Mylotarg, reached the market almost two decades ago. Since this time, the ADC field has undergone slow but transformative enhancements, with improvements to technologies and advancements in the pipeline leading to an invigoration of the field. The past couple of years have seen the approvals of three new ADCs: Polivy, Lumoxiti, and Besponsa, increasing the total number of ADCs approved by regulators worldwide to six. These approvals mark the start of a new era in which the ADC field is finally beginning to realize its full potential. With the ADC pipeline swelling to around 250 novel candidates in various stages of preclinical and clinical development, approvals for more ADCs appear firmly on the horizon.
Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents.
As a supplement to our well-known quarterly Outlook report, Biomedtracker is pleased to present a longer-term look at some key late-stage drugs projected to hit the market in 2021.
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Health technology assessments (HTAs) have become an integral part of procedures employed to inform new drug coverage and pricing decisions across Europe. Methodological approaches to HTA vary, however, while disparities are also apparent in the pertise and financial resources to conduct multidisciplinary assessments, and in the relative weight accorded to recommendations issued by national (or regional) HTA agencies (ICOM, 2017)
This report provides an in-depth analysis of the market access climate in emerging pharmaceutical markets. Focusing in particular on the E7 countries (Brazil, Russia, India, China, Mexico, Indonesia, and Turkey), it charts recent developments, assesses their potential impact on market access, and pinpoints areas in which further change is anticipated.
Emerging markets account for approximately 18% of the global vaccines market, which is valued at more than $24bn. However, there are indications that this is an underestimate, and some observers forecast that the overall marketplace will reach $50bn by the mid2020s.
By any standards, last year was a turbulent one for the pharmaceutical sector. The patent cliff claimed some of the industry’s most profitable properties and with the market share of these drugs losing ground to generics, put even more pressure on the top- and bottom-line performance of key players such as Eli Lilly and AstraZeneca, to name just two of the worst hit.
Such pressure – and the drive to cut fixed costs that goes with it – has been a boon for clinical CROs, which have become increasingly indispensable to the business of drug discovery, as clinical development is outsourced and specialist units, such as clinical laboratories, are offloaded to CROs in long-term guaranteed strategic partnerships.
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