Safe Biologics

JANUARY 12, 2024

The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted.

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Biosimilars Drug Pricing 130

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.

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Biosimilars Documentation Drug Pricing 130

Express Pharma

JULY 14, 2023

herapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global phase III Intas Pharma announced that the European Medicine Agency (EMA) confirms acceptance of the Marketing Authorisation Application (MAA) for DMB-3115, a biosimilar of Stelara (Ustekinumab).

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Biosimilars 98

RX Note

DECEMBER 25, 2024

However, with the proliferation of biosimilars and liposomal or pegylated forms, health care professionals are now encouraged to communicate using product name for certain circumstances (e.g. bioavailability differences, release profile variations, biologics and biosimilars , licence variations and patient factors) to avoid confusion.

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Biosimilars Community Pharmacies Labelling Communication 52

European Pharmaceutical Review

JANUARY 31, 2025

Over 100 biosimilar medicines are approved for nearly 30 reference medicines, testimony to the rigour of the scientific standards leading to the European authorisation process. This makes biosimilar medicines highly relevant. A significant number of the possible biosimilar candidates are not blockbuster medicines.

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Biosimilars 52

pharmaphorum

FEBRUARY 24, 2021

Higher biosimilar savings. Spain, like many European countries, have seen biosimilars as a route to helping manage pressure on health care spending. Back in 2020 savings from biosimilars were forecasted to really get going in that year and through to 2022.

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pharmaphorum

SEPTEMBER 16, 2021

Since their inception in 2013, Clinical Commissioning Groups (CCGs) have led medicines optimisation efforts at local level. Promoting automatic substitution of, for example, biosimilars on formularies and registers could accelerate conversion to use of biosimilars, releasing significant financial savings.

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Biosimilars Community Pharmacies Medical Records Documentation 113

pharmaphorum

OCTOBER 28, 2022

Angela spent a decade in pharma sales and marketing management roles with MSD and BMS, prior to staring the world’s second market access agency in 1998, which she sold to IMS Health in 2013. She is an SME in market access, rare disease and biosimilars.

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Biosimilars 122

European Pharmaceutical Review

NOVEMBER 8, 2022

2) limiting the scope and number of patents asserted in litigation against proposed biosimilar entrants. 4) prohibiting ‘product hopping’ and interference with generic and biosimilar substitutions. 5) monitoring access to biosimilars. 3) policing anticompetitive settlements between competing drug manufacturers.

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Biosimilars Drug Pricing Pharmaceutical Manufacturing Pharmaceutical Companies 52

Big Molecule Watch

AUGUST 21, 2023

In its complaint, GSK claims that Pfizer “knowingly uses GSK’s claimed inventions in ABRYSVO without permission” and that Pfizer “began the project that led to ABRYSVO no earlier than 2013, at least seven years after GSK started its own RSV program.”

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Vaccines Immunity Immunization Biosimilars 52

pharmaphorum

SEPTEMBER 28, 2020

Professor Mohamad Mohty, head of haematology and cellular therapy at Saint-Antoine Hospital, told the webinar audience: “It is really amazing to see the number of haematology indications, whether for new molecular entities or for biosimilars.”. for the period from 2007-2013. for the period from 2007-2013.

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Biosimilars Hospitals 105

pharmaphorum

FEBRUARY 18, 2021

Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. 6 The stakes were extremely high, with annual costs of insulin reaching $736 per patient in 2013, up threefold since 2002. In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog.

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Prescription Filling Drug Pricing Biosimilars Compounding 52

PharmaShots

JUNE 28, 2023

The co-promotion collaboration agreement between the two companies in the United States and Canada expired on October 31, 2013. Some of the alternative drugs for Enbrel include: Enbrel’s Biosimilars6 As Enbrel has a long journey in the market it is already facing competition from biosimilars in the US and other countries.

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Biosimilars Insurance Coverage and Processing Dosage Compounding 40

FDA Law Blog: Biosimilars

JUNE 17, 2024

OPQ reports that the vast majority of the 81 drug shortages reported in CY2022-23 were due to quality issues (40%) and increase in demand (40%)—a significant change from 2013-2017 when quality issues were the cause of 62% of shortages.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Will DOJ and DEA continue to exercise the enforcement discretion generally shown since the Cole Memo was issued in August 2013? Were DEA to reschedule marijuana to schedule II or III, or leave it in schedule I, and the states regulate it in a less restrictive schedule or allow continued recreational use, how will the U.S.

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FDA Law Blog: Biosimilars

DECEMBER 13, 2023

However, our research reflects that of the orphan-designated novel drugs approved since 2013 by DRDMG or its predecessor, the Division of Gastroenterology and Inborn Errors Products (DGIEP), only 1 out of 18 went to an advisory committee meeting. irritable bowel syndrome, primary biliary cholangitis).

Drug Development 59

Drug Development 59

FDA Law Blog: Biosimilars

MARCH 27, 2023

The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA. FDA has been implementing the UDI system with different compliance dates for different types of medical devices to ensure a smooth implementation. Most of the compliance dates have been passed.

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Labelling Packaging Documentation 45

FDA Law Blog: Biosimilars

AUGUST 27, 2023

As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023.

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Packaging 52

Safe Biologics

AUGUST 23, 2024

as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S. In the U.S., In the U.S.,

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Biosimilars Chemotherapy Packaging 130

FDA Law Blog: Biosimilars

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA.

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Compounding Hospitals Labelling 52

pharmaphorum

JANUARY 14, 2021

Biosimilars accelerate. Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. 2021 marks the start of the era when these healthcare systems really need biosimilars to come good on their promise to realise cost savings. Focus on customer engagement impact.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 71

Safe Biologics

OCTOBER 10, 2023

As we intended, this approach has been incredibly successful in controlling costs: the Congressional Budget Office projected drug spending between 2004-2013 to be $770 billion; actual expenses were 45% lower- at $421 billion. director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.

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Biosimilars Drug Pricing Drug Development 130

FDA Law Blog: Biosimilars

AUGUST 29, 2024

Shumsky — As readers of this blog know ( see, e.g. , here ), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. 2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful. Karst & Michael D. Actavis, Inc. ,

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Biosimilars 59

European Pharmaceutical Review

OCTOBER 19, 2022

2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.” 23 April 2013. Santa Clara High Technology Law Journal. 29(3), article 2.

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Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

pharmaphorum

OCTOBER 9, 2020

It is also hoping to steal market share from rivals with biosimilars, which are comparatively cheaper versions of biologic drugs. Amgen has been working on the drug with Cytokinetics since 2006, and Servier bought European rights in 2013. Psoriasis drug Otezla is also bringing in the bucks – but Amgen paid $13.4

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Biosimilars 52

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. Company: Supernus Pharmaceuticals Generic Name: Topiramate First Approval Date: Aug 16, 2013 Patent Expiration: Jan 2023 2022 Sales: $261.2M As of now, there are no the US FDA approved biosimilars available for Actemra.

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Biosimilars Diabetes Chemotherapy Immunity 49

FDA Law Blog: Biosimilars

APRIL 8, 2024

FDA previously analyzed 163 drugs that went into shortage in the 5-year period between 2013 and 2017; 63% (103) were sterile injectables and 67% (109) were drugs that have a generic version on the market. That sterile injectables may be more vulnerable to supply change disruptions is not a novel concept.

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Inpatient Hospitals Dosage Controlled Substances 59

FDA Law Blog: Biosimilars

MARCH 14, 2023

Attorneys in August 2013 that DOJ was unlikely to take enforcement action against marijuana-related businesses operating in compliance with state law unless the businesses implicated any one of eight enforcement priorities. 29, 2013), 3. Deputy Attorney General James Cole advised U.S.

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STAT

FEBRUARY 21, 2024

… AbbVie announced that chief executive officer Richard Gonzalez, who has managed its ascent since being spun off from Abbott Laboratories in 2013, will step down in July , STAT notes. He will be replaced by chief operating officer Robert Michael, who, like Gonzalez, is a longtime AbbVie executive.

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Biosimilars 260

Safe Biologics

SEPTEMBER 11, 2023

As we intended, this approach has been incredibly successful in controlling costs: the Congressional Budget Office projected drug spending between 2004-2013 to be $770 billion; actual expenses were 45% lower- at $421 billion.

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Drug Pricing Biosimilars Vaccines Drug Development 150

Safe Biologics

NOVEMBER 14, 2024

SAVE THE DATE: ASBM and GaBI to Present Webinar on the Biosimilar Red Tape Elimination Act October 31st On October 31st, ASBM and the Generics and Biosimilar Initiative will present a webinar focusing Senate Bill 2305, the Biosimilar Red Tape Elimination Act. Health policy experts will review current U.S.

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Biosimilars 130

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

To be clear, as we discussed in a blogpost back in 2013 , the Federal Food, Drug, and Cosmetic Act does not explicitly require companies to permit photographs to be taken. FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.”

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Documentation Labelling 113

FDA Law Blog: Biosimilars

MARCH 31, 2025

1096 , the Preserve Access to Affordable Generics and Biosimilars Act ; and (2) S. 2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) announced the introduction of two bills weve seen before: (1) S. While the focus of this post is S.

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Biosimilars 64

FDA Law Blog: Biosimilars

APRIL 2, 2025

1096 , the Preserve Access to Affordable Generics and Biosimilars Act ; and (2) S. 2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) announced the introduction of two bills weve seen before: (1) S. While the focus of this post is S.

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Biosimilars 59

pharmaphorum

JULY 8, 2022

AbbVie’s measures to extend market exclusivity for Humira have attracted considerable attention from lawmakers in recent years, but with adalimumab biosimilars now on the market the focus has shifted to the tax avoidance issue.

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Biosimilars Documentation 59

European Pharmaceutical Review

DECEMBER 23, 2024

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. EMA/CHMP/ICH/353369/2013. EMA/CHMP/ICH/83812/2013. September 1999, CPMP/ICH/365/96. Eglovitch JS. EU Official Says ICH Q6B Is Outdated And Needs Revision. Internet] Regulatory Focus. cited 2024August]. Available from: [link] 4. Pharmaceutics.

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Biosimilars Vaccines 52

FDA Law Blog: Biosimilars

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. The concerns raised by PERA are not limited to these industries, however.

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Biosimilars Vaccines 64