FDA Law Blog: Biosimilars

FEBRUARY 6, 2024

GAO wrote a thorough 2022 report that assessed relative lack of foreign inspections for drug making facilities, and dissected the complex problems that make foreign inspections difficult for FDA. Karst — The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations invited Hyman, Phelps & McNamara, P.C.

Documentation 52

Documentation 52

European Pharmaceutical Review

AUGUST 1, 2022

Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP in 90 countries, subject to required regulatory approvals being obtained. Each year, there are approximately 1.5

Drug Development 79

Drug Development 79

pharmaphorum

JULY 28, 2022

While navigating changes has long been a challenge for the industry, the last two years’ events have made supply chain management significantly more difficult. Supply chain challenges are compounded by the broader global picture, such as the war in Ukraine, the great resignation, and natural disasters. Logistical challenges.

Diabetes 107

Diabetes Dosage Pharmaceutical Manufacturing Documentation 107

Express Pharma

SEPTEMBER 26, 2023

Dr V K Paul, Member, NITI Aayog, S Aparna, Secretary (Pharma), Ministry of Chemicals and Fertilizers and Dr Rajiv Bahl, Director General, ICMR were also present at the event. We need to make policies, new products and new research according to the needs of our country and the world, in consultation with industries and academia.

Biosimilars 100

Biosimilars 100

PharmaState Academy

JANUARY 23, 2024

The event, featuring keynote speeches, presentations, and dynamic discussions, explored critical topics such as brand management, corporate branding, pharmaceutical innovations, and global brand management challenges and strategies for Bangladesh Pharma Industry.

Biosimilars 52

Biosimilars Communication 52

RX Note

APRIL 16, 2023

Introduction Access to health care is a fundamental right, but the rising cost of prescription drugs has made it challenging for many people to afford the medications they need. Suggest generic alternatives to brand-name drugs, which can be much cheaper. Why Drug Prices Are Rising?

Drug Pricing 40

Drug Pricing Documentation Pharmaceutical Companies Pharmaceutical Companies 40

Quality Matters

JUNE 8, 2023

FDA and Center for Research on Complex Generics, as well as at the 8th Global Pharmaceutical Quality Summit hosted by the Indian Pharmaceutical Alliance (IPA) in Mumbai – both taking place this month. The potential for nitrosamine impurities has become an ever-evolving challenge in regions around the world.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

OCTOBER 26, 2021

COVID-19 has made patients much more aware of the length and complexity of pharmaceutical supply chains, as well as how they impact on the environment. “The We certainly have a problem with national-level procurement policies that put almost no value on generic medicines … that approach needs to change.

Generic Medicine 118

Generic Medicine Biosimilars 118

Quality Matters

APRIL 20, 2023

To address this threat, adherence to USP public quality standards helps ensure medicines are safe, work as intended, and are available when needed. While not usually top-of-mind, standards and other quality-focused solutions developed by the U.S. In fact, USP documentary standards are recognized in U.S.

Biosimilars 52

Biosimilars Labelling Vaccines Generic Medicine 52

pharmaphorum

MARCH 10, 2022

Driven by advancements in technology, these complex therapeutics have already made waves in life sciences, providing revolutionary treatment options in oncology, immune conditions and rare diseases. Tapping into the momentum of biologics requires investment but identifying the right areas to invest in is a challenge in an evolving market.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Packaging Immunity 98

pharmaphorum

JANUARY 27, 2023

And, while Europe is on track to survive the current winter, replenishing gas stocks next year is likely to be an even tougher challenge. And, while Europe is on track to survive the current winter, replenishing gas stocks next year is likely to be an even tougher challenge. Governments will act, but will it be enough?

Packaging 100

Packaging Biosimilars Vaccines 100

Express Pharma

JULY 3, 2023

For decades, Waters has been a trusted partner to many pharma and generics companies operating in India, particularly for small molecule QA/QC. Drug company R&D is constantly pressured to improve productivity, provide support across geographies, and navigate complex regulatory environments.

Biosimilars 85

Biosimilars Drug Development Generic Medicine Diabetes 85

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.

Biosimilars 52

Biosimilars Dosage Documentation 52

PharmaState Academy

JANUARY 23, 2024

Dear Pharma Brand Management Enthusiasts We are delighted to provide you with a detailed recap of the insightful discussions that unfolded on Day 1 of the World Pharma Brand Managers Week, a collaborative initiative by PharmaState.Academy and IES’s Management College and Research Centre (IESMCRC).

Communication 52

Communication Diabetes Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JANUARY 24, 2023

The challenge is that the overall volume of interactive engagement, whether virtual or face to face, remains down in Europe, Japan, and China on 2019 levels by between 14% and 37%. In this context, the channel for engagement, although still relevant, is less important than the healthcare professional’s need and the way in which that is met.

Pharmaceutical Companies 97

Pharmaceutical Companies Pharmaceutical Companies Vaccines 97

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. Comments may be submitted here until April 30, 2024.

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

PharmaState Academy

MARCH 1, 2024

Impact of Therapeutic Area: Examine how detailing sessions differ across therapeutic areas, considering factors such as the complexity of the disease, treatment guidelines, and patient demographics. Sales teams may need to adjust their strategies accordingly to differentiate their products and address competitive challenges.

Diabetes 52

Diabetes Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.

Biosimilars 52

Biosimilars Vaccines Drug Development Documentation 52

Putting Patients First Blog

MARCH 15, 2024

This has often led to challenges for people with chronic diseases and disabilities accessing the care they need. Patients need an affordable, functioning employer-sponsored insurance (ESI) system. ERISA is long overdue for Congressional attention, and we appreciate that the RFI starts this process.

Insurance Coverage and Processing 40

Insurance Coverage and Processing 40

European Pharmaceutical Review

FEBRUARY 23, 2023

After the end of the seven-year transitional period, 1 this will include classic European patents (EPs) and supplementary protection certificates based on the EP that have not been opted out. There is no definitive answer as to whether life sciences companies should, or should not, opt their EPs out of the UPC. In(novators) or out?

Biosimilars 85

Biosimilars Compounding 85

Quality Matters

MAY 25, 2023

The risk of pharmaceutical impurities that can have serious negative health consequences for patients has become a significant challenge for industry, regulators, pharmacopoeias, and other stakeholders in recent years. Nitrosamine impurities challenges Much of the APEC panel discussion on impurities focused on nitrosamines in particular.

Communication 52

Communication 52

pharmaphorum

SEPTEMBER 9, 2022

Pharma’s reliance on global supply chains and its need for vast quantities of water make it particularly vulnerable to climate change. But preparing to adapt to the phenomenon presents an opportunity as well as a challenge. Just as in the wake of COVID-19, the world will look to pharma to fulfil its public health needs.

Pharmaceutical Companies 101

Pharmaceutical Companies Pharmaceutical Companies Vaccines 101

Pharmaceutical Technology

JANUARY 10, 2023

Type 2 diabetes (T2D) is a crowded and competitive landscape with multiple “me-too,” generic and biosimilar drugs entering the market, with market growth primarily driven by an increasing prevalent population across nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, China, and India).

Biosimilars 52

Biosimilars Labelling Diabetes Compounding 52

Putting Patients First Blog

APRIL 29, 2024

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

Documentation 40

Documentation Insurance Coverage and Processing Communication Pharmacy Technician 40

Putting Patients First Blog

APRIL 10, 2024

People with chronic diseases and disabilities often face significant logistical, economic, and other challenges to accessing care in clinical settings. The NHC supports efforts to increase access to needed care in the home, including better access to telehealth.

Packaging 40

Packaging Communication 40

Putting Patients First Blog

MARCH 28, 2023

Addressing transparency and competition is an important part of helping patients access and afford the care they need. Patients Need More Information The current health care system is fragmented, opaque, and often driven by misaligned incentives. We promote increased access to affordable, high-value, sustainable health care.

40

40

pharmaphorum

APRIL 16, 2021

It is undeniable that 2020 was a particularly challenging year to launch non-COVID innovative prescription medicines. Both the FDA and the EMA rose to the pandemic regulatory challenge very well – addressing the specific COVID treatment and vaccination needs, as well as keeping standard medicines approvals going.

Pharmaceutical Companies 85

Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 85

European Pharmaceutical Review

DECEMBER 19, 2022

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Biosimilars therefore do not qualify as copies (or ‘generic’ versions) of the reference product. Are biosimilars interchangable?

Biosimilars 52

Biosimilars 52

Pharmaceutical Technology

NOVEMBER 29, 2022

For several decades, researchers have been investigating the role of ketamine in treating depression. Now, efforts are underway to study ketamine’s effects in Parkinson’s disease, fibromyalgia, and Rett syndrome. In 1970, the FDA approved ketamine as an anesthetic. The drug is also known for its illegal recreational use.

Pharmaceutical Companies 110

Pharmaceutical Companies Pharmaceutical Companies Labelling 110

Putting Patients First Blog

MARCH 4, 2024

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Hospitals 40

Pharmaceutical Technology

JULY 25, 2022

With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market.

Biosimilars 119

Biosimilars Medical Schools Dosage 119

Putting Patients First Blog

MARCH 4, 2024

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Hospitals 40

Putting Patients First Blog

FEBRUARY 6, 2024

Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

Communication 40

Communication Documentation Drug Development 40

Putting Patients First Blog

MARCH 20, 2023

We appreciate that you are reaching out broadly to identify challenges and solutions to this important issue. The needs of people with chronic diseases and disabilities and how they interact with the health care system can look different. We promote increased access to affordable, high-value, sustainable health care.

Hospitals 40

Hospitals 40

Putting Patients First Blog

MARCH 20, 2023

We appreciate that you are reaching out broadly to identify challenges and solutions to this important issue. The needs of people with chronic diseases and disabilities and how they interact with the health care system can look different. We promote increased access to affordable, high-value, sustainable health care.

Hospitals 40

Hospitals 40

Putting Patients First Blog

JUNE 5, 2023

Other members include health- related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication 40

pharmaphorum

JANUARY 5, 2022

Add to this the fact that the world missed the WHO targets for global vaccination by the end of 2021 and will likely continue to miss targets in 2022. Although the Pandemic is a long way from over, events and trends are starting to clarify the shape of the post-pandemic pharmaceutical and healthcare world.

HIV Treatment and Prevention Agents 95

HIV Treatment and Prevention Agents Vaccines 95