Big Molecule Watch

SEPTEMBER 28, 2023

Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin aspart, insulin lispro, and insulin glargine) in the U.S. Meitheal and Tonghua Dongbao will be jointly responsible for development and supply, with the expectation of achieving FDA approval in 2026.

Biosimilars 57

Biosimilars 57

European Pharmaceutical Review

SEPTEMBER 26, 2023

The European Commission (EC) has granted Sandoz the first marketing authorisation of biosimilar Tyruko ®* (natalizumab). Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. The site is planned to be completed by 2026.

Biosimilars 59

Biosimilars Dosage Packaging 59

Big Molecule Watch

JULY 27, 2023

On July 20, 2023, Sandoz announced that it plans to invest approximately $90 million to build a Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026. The post Sandoz Invests in New Biosimilar Manufacturing Facility appeared first on Big Molecule Watch.

Biosimilars 52

Biosimilars 52

Big Molecule Watch

NOVEMBER 6, 2023

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA. In that case, according to CMS’s guidance, STELARA would cease to be “selected” on January 1, 2027.

Drug Pricing 67

Drug Pricing Biosimilars 67

Express Pharma

AUGUST 8, 2024

The global obesity market faces supply issues, prompting Chinese pharma companies to leverage the situation to develop GLP-1 biosimilars. In July 2023, China approved Huadong Medicine’s biosimilar of Novo Nordisk’s once-daily subcutaneous GLP-1 agonist injection liraglutide for obesity; a few more liraglutide biosimilars are in the pipeline.

Biosimilars 84

Biosimilars Diabetes 84

STAT

APRIL 4, 2024

A drugmaker in China has developed a biosimilar version of Novo Nordisk’s popular diabetes drug Ozempic and applied for approval to sell it there, in a potential challenge to Novo expansion plans in the country , Reuters writes. Continue to STAT+ to read the full story…

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Diabetes Biosimilars 251

Pharmaceutical Technology

JULY 20, 2023

The centre is planned for completion in 2026, along with plans to build a $400m biologics manufacturing plant.

Biosimilars 74

Biosimilars 74

European Pharmaceutical Review

OCTOBER 4, 2023

Going forward, the company will continue to focus on developing generic and biosimilar medicines for the European medicines market, with focus on sustainable access. This would position the Ljubljana site as key location for its biosimilar product development, the company stated. This is about 25 percent of the total cost.

Biosimilars 105

Biosimilars 105

European Pharmaceutical Review

MARCH 13, 2023

The “state-of-the-art” site will enable Sandoz “to meet growing demand for our current and future biosimilars in the mid- to long-term,” noted Glenn Gerecke, Global Head of Sandoz Technical Operations. The new plant will support the growing biosimilars sector. Full operations is provisionally planned for late 2026.

Biosimilars 97

Biosimilars 97

Safe Biologics

OCTOBER 10, 2023

A Better Reform: Ensuring Savings Are Passed Onto Patients While price-setting proponents say beneficiaries will start to see lower drug prices beginning in 2026, there’s no evidence that this is true, and there are better ways to lower out-of-pocket costs- and much faster, Reilly explains.

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Biosimilars Drug Pricing Drug Development 130

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 93

Biosimilars 93

STAT

NOVEMBER 1, 2023

As Medicare prepares to negotiate prices for its first batch of medicines, an advocacy group argues the agency should factor in controversial patent maneuvers for one drug that will have cost the program nearly $2 billion in additional spending by 2026 , STAT writes. At

Biosimilars 258

Biosimilars 258

Express Pharma

JANUARY 11, 2024

Following these, the US market anticipates the 2026 introduction of additional URAT1 inhibitors – ABP-671 and SAP-001 – along with tigulixostat, a xanthine dehydrogenase inhibitor, and a topical sodium bicarbonate therapy.” Canakinumb, set for a 2030 launch, is a biosimilar to the established Ilaris therapy.

Biosimilars 86

Biosimilars Compounding 86

FDA Law Blog: Biosimilars

MARCH 19, 2024

Hyman, Phelps & McNamara, P.C. (HP&M), HP&M), the largest dedicated food and drug law firm in the U.S., is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). This prestigious appointment recognizes Ms.

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Pharmaceutical Technology

MARCH 10, 2023

Sandoz, a division of Novartis , has signed a Memorandum of Understanding (MoU) for constructing a new biologics production plant in Lendava, Slovenia, to support the growing demand for biosimilar medicines worldwide. At Sandoz, we are determined to continue leading the way in driving access to these critical medicines.

Biosimilars 52

Biosimilars 52

Big Molecule Watch

DECEMBER 28, 2023

Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the Big Molecule Watch. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. Reddy’s Laboratories Ltd. (“Dr.

Biosimilars 67

Biosimilars Labelling 67

FDA Law Blog: Biosimilars

MARCH 5, 2024

AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. The court found numerous flaws with this argument.

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Dosage Drug Pricing 62

Big Molecule Watch

AUGUST 25, 2023

With the IRA, Congress changed the pricing model for certain “high-priced” Medicare-covered drugs without generic or biosimilar competition. The MFP will then be published on September 1, 2024, and will take effect on January 1, 2026. The process for the Drug Price Negotiation Program is as follows: Drug Selection.

Drug Pricing 40

Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

Regarding CDER’s ETP, the current ETP guidance document, originally published in 2017, will be updated by the end of 2026, and will include details on communicating the type of products and stages of development for which a requestor can approach the ETP.

Documentation 57

Documentation Communication 57

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

That means almost certainly no sooner than the second half of 2026. Notably, the proposed order provides that the order, if finalized, will become effective one year after the final rule is published.

Pharmacy Management 108

Pharmacy Management Dosage Documentation 108

FDA Law Blog: Biosimilars

JUNE 26, 2023

September 1, 2023 will be the selection date for the 10 drugs that will be subject to “maximum fair price” ceilings under Medicare Part D starting in 2026. Chamber of Commerce makes all the arguments that the other plaintiffs have made, and also alleges that Congress has no power to levy the excise tax because it “compels” commerce.

Drug Pricing 57

Drug Pricing 57

pharmaphorum

APRIL 21, 2022

Without that effect the underlying growth was 5%, with rising use of biosimilars offsetting increased use of branded medicines, although IQVIA notes that the pharma sector has demonstrated “resilience and flexibility” in staging such a rapid recovery in the last two years.

Vaccines 52

Vaccines Biosimilars 52

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

European Pharmaceutical Review

SEPTEMBER 11, 2023

has entered into an agreement with Sandoz to commercialise SB17, a proposed biosimilar to Janssen Pharmaceuticals’ Stelara ( ustekinumab ). About the biosimilar development deal This agreement will help to expand access to biosimilar medicines , according to Samsung Bioepis. Samsung Bioepis Co.,

Biosimilars 96

Biosimilars 96

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026. After this date, without action by Congress, FDA’s authority to grant rare pediatric disease designations would expire, and no vouchers could be granted unless previously granted such a designation.

Documentation 62

Documentation Drug Development 62

FDA Law Blog: Biosimilars

JUNE 14, 2023

In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).

Communication 44

Communication 44

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

One of the major changes is the extension of the transition period from one to two years, with FDA now planning to enforce the QMSR requirements upon the effective date of the final rule on February 2, 2026.

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Labelling Packaging Documentation 57

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026.

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Labelling Communication 62

Pharmaceutical Technology

JANUARY 31, 2023

While insulin price caps will begin this year, larger effects will be delayed until 2026 – when the US federal government will be allowed to negotiate Medicare prices and demand rebates from drug companies that price gouge. That leaves three years for pharma companies to prepare.

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Drug Pricing Biosimilars Drug Development 52

FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Priority is given to Suitability Petitions that could mitigate or resolve a drug shortage; address a public health emergency declared by HHS; mitigate waste by way of new strengths for parenteral products; or subject to special review under the President’s Emergency Plan for Aids Relief.

Dosage 57

Dosage 57

Express Pharma

SEPTEMBER 7, 2023

Adalimumab biosimilars are reshaping the landscape, impacting Humira and competitors like Janssen’s Stelara and Takeda’s Entyvio. However, as with Humira, revenues from these therapies are expected to decline with the release of their corresponding biosimilars, which are anticipated to enter the market in the coming years.

Biosimilars 52

Biosimilars 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.

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Labelling Drug Pricing Compounding Payment Processing 104

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

Note that Astellas withdrew its lawsuit after none of its drugs were selected for price reduction in 2026—potentially because that fact cut against its argument for standing. Harm The Court reviewed the parties’ arguments on “irreparable harm to Plaintiffs.”

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Drug Pricing Pharmaceutical Manufacturing Immunity Immunization 57

Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

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Biosimilars Drug Pricing Documentation Labelling 130

pharmaphorum

JUNE 29, 2022

COVID vaccines and treatments have created a substantial market over and above the existing Rx market- IQVIA estimates that the cumulative value of COVID vaccines could be between $185 and 295bn to 2026. Sarah holds a degree in biochemistry from Oxford University.

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HIV Treatment and Prevention Agents Vaccines Pharmaceutical Companies Pharmaceutical Companies 59

FDA Law Blog: Biosimilars

JULY 7, 2024

Labeling We note that while labeling requirements are not being phased in until stage 2 (May 6, 2026), the regulatory requirements in stage 1 appear to assume that at least some labeling requirements – such as UDI, which must be included in complaint files – will already be implemented).

Labelling 62

Labelling Communication Documentation 62

Express Pharma

NOVEMBER 2, 2023

Though the entry of biosimilars will contract the market, significant growth is expected over the next 8-10 years, driven by the launch of new assets. The anticipated launches in the US and Europe of Janssen’s Tremfya (guselkumab) and Lilly’s mirikizumab, in Q4 2025 and Q3 2026, respectively, are expected to shape the market.

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Biosimilars Compounding 80