pharmaphorum

SEPTEMBER 16, 2021

Promoting automatic substitution of, for example, biosimilars on formularies and registers could accelerate conversion to use of biosimilars, releasing significant financial savings. But in some areas of prescribing national leadership is needed to accelerate and support local systems’ medicines optimisation efforts.

Biosimilars 113

Biosimilars Community Pharmacies Medical Records Documentation 113

pharmaphorum

FEBRUARY 23, 2021

IQWiG sees far less promise in other RWE sources such as electronic medical records and billing records of insurers. Meanwhile, just like many countries, the Germans have seen the potential for savings from the use of biosimilars. In 2021 we might see the ripples from such policies come into the market.

Biosimilars 90

Biosimilars Medical Records 90

Express Pharma

JULY 15, 2024

With the Indian Pharmaceutical sector trying to reach the USD 130 Billion target by 2030, there is a renewed spirit of research in the areas of cell and gene therapy, new molecular entities, biologics and biosimilars.

Medical Records 105

Medical Records Biosimilars Pharmaceutical Companies Pharmaceutical Companies 105

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements.

Documentation 105

Documentation Medical Records 105

FDA Law Blog: Biosimilars

MAY 13, 2024

There is ample data collected on them during this 24/7 monitoring period such as case notes, contemporaneous patient medical records, and patient tapes. Every use of ESD is recorded, as is every behavior that falls within the intended use. Patients that use ESD undergo continuous 24/7 monitoring.

Medical Records 111

Medical Records Documentation 111

Express Pharma

APRIL 12, 2023

However generic companies are now foraying into ‘biosimilars which is a niche and expensive space. New, niche and underserved markets may be spotted by analysing information from social media, demographics, electronic medical records and other sources of data.

Medical Records 97

Medical Records Biosimilars Pharmaceutical Companies Pharmaceutical Companies 97

FDA Law Blog: Biosimilars

OCTOBER 18, 2023

electronic health records, claims). These include: results of pre- and post-market clinical investigation(s) of the device (i.e.,

Medical Records 64

Medical Records 64