Last Week in Review: 2/22/2021 – 2/26/2021

Date: March 1, 2021 | Country: BELGIUMCANADA-ONTARIOHUNGARYITALYJAPAN
RUSSIASOUTH KOREASPAINUNITED KINGDOMUNITED STATES | Region: AFRICAASIA & SOUTH PACIFICEUROPE | Type: Policy | Keywords: #biosimilar #policy  #vaccine # covid19 # drugapproval # druglaunch # pandemic 

PRICENTRIC BRIEF:

  • The National Institute for Health and Care Excellence (NICE) in the U.K. has prepared draft guidance on BioMarin’s Kuvan (sapropterin dihydrochloride) for treating hyperphenylalaninaemia in people with phenylketonuria (PKU), and made it available for public consultation and comment
  • Bristol-Myers Squibb (BMS) and bluebird bio have announced that results from the Phase 2 KarMMa study of investigational B-cell maturation antigen (BCMA)-directed CAR-T cell therapy idecabtagene vicleucel (ide-cel) have been published in the New England Journal of Medicine, a month ahead of the Prescription Drug User Fee Act (PDUFA) target action date of March 27, 2021 for the United States Food and Drug Administration (FDA) to make a decision
  • Pfizer and BioNTech’s Comirnaty has become the first COVID-19 vaccine to secure full approval from Brazil’s National Health Surveillance Agency (ANVISA)

 

THE DETAILS

COVID-19

Dr. Reddy’s Labs has commenced the Emergency Use Authorization (EUA) process with the Drugs Controller General of India (DCGI) for COVID-19 vaccine candidate Sputnik V.

German Health Minister Jens Spahn has expressed the want to assemble a special task force aimed at boosting investment in vaccine production and building up reserve capacity for the next pandemic, speaking at a weekly press conference.

On 17 February, the European Commission presented its new “HERA Incubator”, a European bio-defense preparedness plan against potential COVID-19 variants.

U.S. Food and Drug Administration (FDA) briefing documents have revealed that Johnson & Johnson’s COVID-19 vaccine candidate, dubbed Ad26.COV2.S, has been found to be safe in clinical trials.

This week, Hungary became the first European Union (EU) Member State to start using China-based Sinopharm’s COVID-19 vaccine, after initial batches of the vaccine arrived in Budapest last week.

The African Union (AU) is now supporting efforts to waive some intellectual property (IP) rights for COVID-19 vaccines and therapeutics in order to expedite their arrival to lower-income countries.

REGULATION

AstraZeneca (AZ) has voluntarily withdrawn Imfinzi (durvalumab) from its advanced bladder cancer indication in the US following disappointing results from the Phase III DANUBE trial.

The National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) in China has granted Breakthrough Therapy Designation (BTD) to Innovent and IASO Biotherapeutics’ investigational CAR-T cell therapy IBI326/CT103A for the treatment of relapsed/refractory (R/R) multiple myeloma (MM).

SIRION Biotech has signed a license and collaboration agreement with Sanofi to develop improved tissue-selective adeno-associated virus (AAV) vectors to create gene therapy treatments for disorders affecting major human organs.

This week, ONK Therapeutics and blood cancer charity Anthony Nolan entered into a collaboration for the development of next-generation natural killer (NK) cell therapies with the aim of improving lives of patients suffering from hematological malignancies and solid tumors.

The European Commission has granted orphan medicinal product designation for OCU400, Ocugen’s gene therapy candidate for the treatment of both retinitis pigmentosa (RP) and Leber Congenital amaurosis (LCA).

Led by former AveXis leadership and created in collaboration with Deerfield Management, Jaguar Gene Therapy launched yesterday to accelerate the development, manufacturing, and commercialization of novel gene therapy treatments for patients with severe genetic diseases.

Merck – or MSD outside the United States (U.S.) – has announced a definitive agreement to buy Pandion Therapeutics for a total equity value of $1.85 billion, or $60 per share in cash.

PRICING & REIMBURSEMENT

At the start of 2021, Janssen’s Erleada (apalutamide) was included on Russia’s List of Vital and Essential Drugs (VED) for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) and hormone-sensitive prostate cancer.

At its meeting this week, South Korea’s Health Insurance Review and Assessment Service (HIRA) decided to reimburse two medicines for cancer and one for degenerative eye disease.

The Federal Institute for Drugs and Medical Devices (BfArM) in Germany has greenlighted the reimbursement of Deprexis, Servier’s online therapy program for patients with unipolar depression or depressed mood.

At the end of January, Sanofi’s Dupixent (dupilumab) was officially listed under China’s National Health Insurance Drug Catalogue for use through the Basic Medical Insurance (BMI) scheme for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is inadequately controlled with topic therapies or when these therapies are not advisable.

Belgium’s National Institute for Health and Disability Insurance (NIHDI) has announced that medical apps can now be reimbursed in Belgium, following the submission of data showing that their medical apps provide clinical and socio-economic value to end-users.

The Italian Medicines Agency (AIFA) has approved the reimbursement of Darzalex (daratumumab) when used in combination with lenalidomide and dexamethasone or bortezomib, melphalan and prednisone for patients with multiple myeloma.

BIOSIMILAR

Fresenius Kabi has launched its adalimumab biosimilar Idacio in Canada for all rheumatology, gastroenterology, and dermatology indications of the reference product, AbbVie’s Humira.

The German biopharmaceutical company, Fresenius Kabi, has planned to launch an adalimumab biosimilar referencing Abbvie’s Humira in Australia in the second quarter of 2021 and in Brazil in the third quarter—Meanwhile it would reach the US market much later, in 2023. The company will also launch biosimilars to Neulasta & Actemra among others.

DRUG APPROVAL

The United States Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Incyte’s Jakafi (ruxolitinib) for the treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adults and pediatric patients aged 12 years and up.

The European Commission (EC) has granted Marketing Authorization for Dynavax’s “Hepislav B” Hepatitis B vaccine. The Commission has authorized the vaccine for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, following a European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion.

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization to Seagen’s Tukysa (tucatinib) for HER2-positive locally advanced or metastatic breast cancer in the UK.

The United States Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) for first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express high PD-L1 levels, as determined by an FDA-approved test.

Health Canada has approved Dupixent (dupilumab injection) for the treatment of moderate-to-severe atopic dermatitis (AD) in children aged six to 11 years whose disease is not adequately controlled with topical prescription therapies or when these options are not advisable.

The U.S. Food and Drug Administration (FDA) has approved AbbVie’s Humira (adalimumab) for moderately to severely active ulcerative colitis (UC) in pediatric patients five and older.

The U.S. Food and Drug Administration has granted approval for Sarepta’s Amondys 45 (casimersen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.

POLICY 

The U.S. Food and Drug Administration has issued new guidance for drugmakers developing COVID-19 vaccines, whose candidates target the variants of the virus. The expedited pathway is modeled on the FDA’s extensive experience with evolving viruses and diseases, such as HIV and the flu.

UCB and Microsoft have teamed up through a strategic, multi-year collaboration to leverage Microsoft’s computational services, cloud, and artificial intelligence (AI) to boost UBC’s drug development capabilities by helping scientists to discover new medicines in “a more efficient and innovative way.”

North Dakota’s Senate has passed Senate Bills 2170, 2209, and 2212, which were introduced by Senator Howard Anderson with the aim of helping citizens access lower-cost prescription drugs.

At a recent online press conference, James Feliciano, Chairman of the Executive Committee of PhRMA Japan, urged for comprehensive reform of Japan’s healthcare system, since the government has seemingly moved away from nurturing innovation to instead focus on pricing.

Senators Michael Bennet and Tim Kaine have reintroduced their Medicare-X Choice Act legislation seeking to expand on the Affordable Care Act (ACA) and Medicare to offer families, individuals, and small businesses low-cost health insurance, control healthcare costs, and increase marketplace competition.

Anvisa and the EMA have officially established their commitments surrounding the sharing of information, formalizing cooperation that has been strengthening over the past few years between the two agencies.

The UK’s NHS has released a new commercial framework for new medicines, which outlines the purpose and principles on which NHS commercial medicines activity will be based going forward.

The Spanish Association of Orphan and Ultra-orphan Medicines Laboratories (AELMHU) published its Annual Report on Access to Orphan Medicines in Spain in recognition of World Rare Diseases Day (ERR). Only 5 new drugs were approved in Spain in the last fiscal year, representing a 45% drop in the number of drugs financed compared to 2019, according to the report.

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