Reports
Biosimilars: what patients need to know
Biosimilars are medicines that are similar to a biological medicine that has already been authorized. Biosimilars are different to generics in that they are not identical to their reference product. This is due to the fact that they are derived from living cells and therefore demonstrate molecular complexity and heterogeneity. For this reason biosimilars must be ‘similar but not identical’ to their reference biological with regards to quality, safety, and efficacy.
Endocrinologists need more data to prescribe biosimilars
Endocrinologists require more clinical trial data for biosimilars compared to other specialists, such as oncologists and gastroenterologists, according to a report from research and advisory firm BioTrends Research Group.
Gastroenterologists unlikely to use infliximab biosimilar
Gastroenterologists are unlikely to prescribe an infliximab biosimilar in their Crohn’s disease or ulcerative colitis patients if it has not been clinically tested in inflammatory bowel diseases, according to a report from a research and advisory firm.
Increased use of generics could save South Africa millions
Increasing the use of generics by 5% could save the healthcare industry and patients in South Africa in excess of Rand 400 million per year, according to a report from the country’s pharmaceutical association.
UK biosimilars uptake lower than in some other EU countries
Use of biosimilars in the UK is lower than might be expected when looking at the use of generics in the UK, and it is lower than in some other European countries.
India’s pharma moving from generics to niche drugs
Indian pharmaceutical companies will increasingly move away from the overcrowded and competitive area of generics and invest more R & D spending in niche drugs, according to a new report.
Authorized generics reduce drug prices
In what seems to be a bit of a turnaround for the US Federal Trade Commission (FTC), the agency has released a report which suggests that authorized generics can reduce both retail and wholesale drug prices.
Ireland’s drug shortages worsening
Drug shortages in Ireland have increased during the last 12 months, according to a recent survey of pharmacists in the country.
How to avoid drug shortages
Despite FDA having made progress in recent years to combat drug shortages, the issue is still a major problem for the agency. This very fact led to the agency requesting public comment on the subject in February 2013. Senior Vice President of Quality at Amgen, Mr Martin Van Trieste, makes some suggestions to ensure that patients continue to gain access to essential medicines [1].
US healthcare professionals need more education on biosimilars
A study of healthcare professionals in North America found a lack of knowledge concerning biosimilars and a need for further education on biosimilars.