pharmaphorum

FEBRUARY 28, 2022

India’s Biocon has expanded its pipeline of biosimilars with a $3.3 Biocon’s partnership with Mylan – which merged with Pfizer’s Upjohn to form Viatris in 2020 – dates back more than a decade and has generated a number of biosimilars including insulin analogues, antibodies and recombinant proteins.

Biosimilars 87

Biosimilars Customer Service 87

Big Molecule Watch

AUGUST 16, 2023

In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “ Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products ” and “ Classification Categories for Certain Supplements under BsUFA III ”, respectively.

Biosimilars 52

Biosimilars 52

FDA Law Blog: Biosimilars

JUNE 28, 2023

By Riëtte van Laack — On June 8, 2023, bipartisan legislation creating a new category of animal feed ingredients, named zootechnical animal food substances, was introduced. CVM maintained that, without new legislation, it does not have the authority to regulate products with these types of claims as feed ingredients.

Labelling 45

Labelling 45

Express Pharma

DECEMBER 19, 2023

Insuquick is a “Make in India” product and is available in all metros, and tier I/II cities USV has announced a partnership with Biogenomics to launch Insuquick, a biosimilar insulin aspart for people with diabetes In India. Insuquick is a “Make in India” product and is available in all metros, and tier I/II cities.

Diabetes 93

Diabetes Biosimilars 93

FDA Law Blog: Biosimilars

APRIL 2, 2024

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

Labelling 104

Labelling Biosimilars Drug Pricing Dosage 104

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C.

Controlled Substances 40

Controlled Substances Drug Pricing Drug Development 40

European Pharmaceutical Review

FEBRUARY 2, 2023

Three categories were available for entry in the Exhibitor Innovations section. The product awarded in the patient-centric design category provides accurate and reliable drug delivery of therapeutic and prophylactic medicinal substances, by intradermal injection. It provides an equal barrier to a traditional aluminium lid or PVC.

Packaging 79

Packaging Medication Delivery Biosimilars 79

European Pharmaceutical Review

NOVEMBER 15, 2023

The €150 million facility in Kundl, Austria will produce the antibiotic penicillin, while the new €25 million facility in Holzkirchen, Germany will be Sandoz’s new Biosimilar Development Center. Launch of these new facilities help to ensure sustainable access to quality antibiotics and spearhead development of biosimilars, Sandoz noted.

Biosimilars 67

Biosimilars 67

Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

Biosimilars 130

Biosimilars Drug Pricing Compounding Drug Development 130

Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. The approval of Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to Janssen’s STELARA (ustekinumab) is noteworthy given that it received designation as interchangeable. Below are some of the top regulatory developments from 2023.

Biosimilars 57

Biosimilars Labelling Drug Pricing 57

Pharma Mirror

MARCH 31, 2022

As a response to increasing demand, Pipelinepharma will introduce biosimilar drugs into a separate category. New finished dosage form categories for medical devices and nutraceuticals will also be launched in the coming months. “We

Dosage 52

Dosage Biosimilars 52

Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

Biosimilars 100

Biosimilars Drug Pricing Compounding Drug Development 100

pharmaphorum

AUGUST 11, 2022

Rebecca speaks about generics and biosimilars: what they are, why they’re important for medication access and healthcare cost sustainability, and what Sandoz has learned about succeeding in the off-patent world. Tune in to learn more about the world of off-patent medicines: an important category of medications that isn’t going away.

Biosimilars 52

Biosimilars 52

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.

Biosimilars 52

Biosimilars Drug Pricing Pharmaceutical Manufacturing Pharmaceutical Companies 52

pharmaphorum

DECEMBER 13, 2020

It marks something a departure from AZ’s relentless focus on deal-making in oncology, its top product category, and also comes as Alexion has been locked in a battle with activist shareholders pushing for a sale.

Biosimilars 109

Biosimilars 109

Pharmaceutical Technology

DECEMBER 22, 2022

Business Expansion is one of our largest categories and looks at the core functions of business operations within the sector. The Environmental category aims to highlight companies that are undertaking projects that reduce their impact on the natural environment or contribute to its general health. Business Expansion. Innovation.

Diabetes 52

Diabetes Biosimilars Pharmaceutical Companies Pharmaceutical Companies 52

Pharma in Brief

JUNE 21, 2020

those sold before January 1, 2021, into three categories: Grandfathered (DIN before August 21, 2019), Line Extension (DIN on or after August 21, 2021 for new dosage form/strength of Grandfathered medicine), and Gap (DIN on or after August 21, 2019 and first sale before January 1, 2021).

Biosimilars 40

Biosimilars Generic Medicine Dosage Documentation 40

Pharma in Brief

FEBRUARY 2, 2022

In making these decisions, the Panel considered, among other information: a product’s listing status on existing federal, provincial, and territorial formularies; utilization data; availability of a generic or biosimilar; and information about safe use in pregnant and lactating women. Drug cost was not a consideration.

Insurance Coverage and Processing 59

Insurance Coverage and Processing Biosimilars Diabetes 59

pharmaphorum

AUGUST 4, 2022

Amgen sells a biosimilar version of rituximab so Tavneos slots in alongside that therapy, and the company also gets three early clinical-stage pipeline candidates, namely an oral PD-1/PD-L1 inhibitor and two CC chemokine receptor-targeting drugs for inflammatory diseases.

Biosimilars 89

Biosimilars 89

Drug Channels

OCTOBER 17, 2022

Cannot be combined with special category rates or other offers. Don’t miss the chance to unite with colleagues and master the complexities of pharmacy and distribution models to accelerate patient access! Drug Channels readers will save 10% off when they use code 22DRCH10 and register prior to November 11, 2022.*.

Biosimilars 56

Biosimilars 56

Drug Channels

JUNE 26, 2023

Cannot be combined with special category rates or other offers. View the agenda for Health Systems & Pharma Partnering 2023 to see the complete picture – the program, speakers, and more, and visit www.informaconnect.com/health-systems-partnering for further details and to register. Other restrictions may apply.

Biosimilars 61

Biosimilars 61

pharmaphorum

AUGUST 2, 2022

The switch to an injectable version of the drug could also help to extend the commercial lifespan for Tecentriq and reduce the impact when biosimilars of the IV version reach eventually reach the market – assuming of course Roche can persuade clinicians to switch.

Chemotherapy 103

Chemotherapy Biosimilars 103

pharmaphorum

DECEMBER 20, 2021

Novartis’ big-selling IgE inhibitor Xolair has been a mainstay of treatment for chronic spontaneous urticaria (CSU) for many years, but with biosimilars looming the company has been looking to follow-up ligelizumab to defend the franchise. Partner Roche meanwhile recorded $1.5 billion in sales from the drug over the same period.

Biosimilars 64

Biosimilars 64

Drug Channels

OCTOBER 15, 2023

Cannot be combined with special category rates or other offers. Drug Channels readers will save 10% off when they use code 23DRCH10 and register prior to November 10, 2023.* * Cannot be combined with other offers or used towards a current registration. Other restrictions may apply. Drug Channels, or any of its employees.

Drug Pricing 55

Drug Pricing Biosimilars 55

pharmaphorum

JULY 22, 2021

The big pharma is already a big player in the $20 billion breast cancer category, with drugs like CDK4/6 inhibitor Ibrance (palbociclib), PARP inhibitor Talzenna (talazoparib), hormonal therapy Aromasin (exemestane) and trastuzumab biosimilar Trazimera.

Biosimilars 114

Biosimilars 114

pharmaphorum

DECEMBER 21, 2020

It marks something of a departure from AZ’s relentless focus on deal-making in oncology , its top product category, and also comes as Alexion has been locked in a battle with activist shareholders pushing for a sale.

Biosimilars 126

Biosimilars Chemotherapy Immunity Immunization 126

Drug Channels

NOVEMBER 8, 2021

LANDSCAPE ADDRESS: Analyze Market Dynamics and Trends Impacting the Channel in an Ever-Changing Environment POLICY ADDRESS: Break Down Evolving Regulatory Reform Driving Innovation and Access Predict Novel Reimbursement Mechanisms and First Pharmacy Benefits for Biosimilars Download your copy of the agenda today and join Informa Connect in December!

Specialty Pharmacies 68

Specialty Pharmacies Biosimilars 68

pharmaphorum

JULY 4, 2022

Hughes will take charge of an R&D unit spending around $1 billion on R&D across Teva’s generics, biosimilars and speciality medicines categories – two-thirds spent in the US – at 26 R&D sites worldwide, employing around 3,500 scientists. He will be based out of Teva’s US headquarters in Parsippany, New Jersey.

Generic Medicine 52

Generic Medicine Biosimilars 52

Pharma in Brief

OCTOBER 25, 2020

Vaccines to be subject to the same complaints-based investigation criteria as patented biosimilars and generics”. Allowing for increases in the Maximum Rebated Price for Category I new medicines to the Maximum List Price level”.

Biosimilars 52

Biosimilars Documentation Vaccines 52

Drug Channels

JULY 11, 2022

Offer applies to current rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration. Drug Channels readers will save 10% off the current registration rate when they use code 22DC10 *. Offer not valid on workshop only or academic/non-profit registrations.

Specialty Pharmacies 81

Specialty Pharmacies HIPAA Biosimilars 81

pharmaphorum

SEPTEMBER 9, 2022

” Eylea remains the leader in the category, with sales of around $8 billion a year, but has started to see its share whittled away by new therapies, like Roche’s fast-growing bispecific antibody Vabysmo (faricimab), which binds to VEGF – the same target as Eylea – as well as Ang-2, to give a double mode of action.

Diabetes 52

Diabetes Biosimilars Labelling 52

FDA Law Blog: Biosimilars

MARCH 15, 2023

Topics will include FDA and USDA regulatory compliance and enforcement, inspections, recalls, food safety technology, and emerging and growing product categories such as cell-cultured meat and Cannabis ingredient-infused products.

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pharmaphorum

MAY 24, 2022

There is heavyweight competition in the biologics category from the likes of Johnson & Johnson’s IL-23 inhibitor Stelara (ustekinumab) as well as AbbVie’s TNF inhibitor Humira (adalimumab) and lower-cost biosimilars.

Biosimilars 59

Biosimilars 59

pharmaphorum

APRIL 28, 2021

” Along with Cosentyx and Taltz, the psoriasis market is already served by TNF inhibitors – including lower-cost biosimilars – as well as Bausch Health’s IL-17 drug Siliq (brodalumab), and three recently-launched IL-23 inhibitors from Johnson & Johnson (Tremfya), AbbVie (Skyrizi), and Sun Pharma (Ilumya).

Biosimilars 52

Biosimilars 52

FDA Law Blog: Biosimilars

JANUARY 7, 2024

PMRs can also be required for confirmatory studies for accelerated approval, deferred pediatric studies, and studies for products approved under the Animal Efficacy Rule, but those categories of PMRs are not relevant here.

Documentation 59

Documentation Vaccines Drug Development 59

Pharma in Brief

FEBRUARY 13, 2024

BYOOVIZ (ranibizumab) was approved as a biosimilar equivalent to another Novartis drug used for treating wet AMD, LUCENTIS. Relief The Court granted a permanent injunction against the Respondents using the BYOOVIZ trademark in association with specified categories of goods. Samsung Bioepis Co, Ltd. and Biogen Inc., 2044395).

Biosimilars 59

Biosimilars Documentation 59

Eye on FDA

FEBRUARY 10, 2021

In all there were 6 letters containing 13 violations – 6 for risk; 1 for an unsubstantiated claim; 2 for broadening indication; 1 for unapproved use and 3 in the “other” category which included a failure to use the established name in the promotion.

Communication 77

Communication Biosimilars Compounding 77