Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada


  • Health Canada has authorized Hyrimoz on Nov 4, 2020 for marketing in Canada. Hyrimoz has been approved for use in all same indications as reference Humira, including rheumatology, gastroenterology and dermatology
  • A patient support program will be available to patients treated with Hyrimoz providing guidance with reimbursement navigation, financial assistance, administrative support & education for patients
  • Hyrimoz is a fully human TNF blocker. The notice of compliance has been issued for 3 SC dosage forms: 40 mg/0.8 mL & 20 mg/0.4mL in prefilled syringe, 40 mg/0.8 mL in autoinjector

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: PRNewswire

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Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes


  • Abbott’s next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received Health Canada’s approval for adults & children with diabetes
  • The system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high/low without scanning
  • The technology sustains performance for ~14days, providing trends, insights & actionable data on a reader or with the FreeStyle LibreLink mobile app. FreeStyle Libre 2 will be available for people with diabetes aged ≥4yrs. in Canada in the coming months

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BioSpace

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Drug importation from Canada won’t work

I’ve mentioned this in a number of previous posts, but large scale importation from Canada won’t work to bring down US drugs prices. The US market is too large and Canada does not have the supply to meet US demand. Further, policies proposing drug importation from Canada assume that Canadians will be passive actors in this.

Well, Canadians are passive no longer.

Canada has banned mass exports of many prescription drugs. The text of the Canadian health ministry’s order is here and states:

A person that holds an establishment licence must not distribute a drug to another person for consumption or use outside Canada unless the person holding the licence has reasonable grounds to believe that the distribution will not cause or exacerbate a shortage of the drug.

Although the US is named named explicitly as the only country to which mass exporting could create a shortage, clearly US policies were the motivation behind this order. Canadians already face shortages for some drugs before any US importation would go into effect. NPR reports:

Between 10-15% of drugs are in shortage at any given time, and close to half of all marketed drugs in Canada have been in shortage at least once, according to Health Canada. The COVID-19 pandemic has made the situation worse, as demand grows for certain medications used to treat coronavirus infections, the department said. By late October, Canada had experienced 42 serious shortages, compared to about 10 shortages throughout all of 2019.
In any case, the Canadian government thinks the new U.S. rule wouldn’t do much to reduce drug prices in the U.S., since the Canadian market is small and represents only 2% of global pharmaceutical sales.

In fact, another study found that one quarter of prescription drugs in Canada already face short supply. These include shortages for medications such as EpiPens, opioid drugs, and treatments for Parkinson’s disease, schizophrenia, and depression.

Will everyone in the world have access to a Covid vaccine? – video explainer

The hunt for a coronavirus vaccine is showing promise but it is premature to say the end of the pandemic is nigh. Several rich countries have signed a ‘frenzy of deals’ that could prevent many poor nations from getting access to immunisation until at least 2024. Also, many drug firms are potentially refusing to waive patents and other intellectual property rights in order to secure exclusive rights to any cure.

Michael Safi, the Guardian’s international correspondent, explains why ‘vaccine nationalisation’ could scupper global efforts to kill the virus and examines what is being done to tackle the issue

Continue reading…

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19


  • The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second Ab vs PBO for the treatment of symptomatic COVID-19 in the outpatient setting
  • Results: reduction in viral load & rates of symptoms & hospitalization, frequency & types of AEs are similar
  • Health Canada authorized the therapy for the use of bamlanivimab (LY-CoV555) as a treatment for adults & pediatric patients aged≥12yrs. with mild to mod. COVID-19 who weigh at least 40 kg & are at high risk of progressing to severe COVID-19 illness or hospitalization

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Microbioz India

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Novartis launches digital health hub in Canada

Novartis is opening a new digital health innovation hub in Canada to help develop “scalable, digital solutions” for patients and healthcare providers.

The Canadian Biome Digital Innovation Hub will be based in Montreal at the artificial intelligence research institute, Mila. The institute formed a strategic alliance with Novartis in 2019.

Canada is the latest country to join a global network of hubs opened by Novartis. The company has established centres in the US, UK, France and India.

The Canadian Biome has already struck a partnership with Canadian virtual care specialist company Insig Health to launch a digital health accelerator. Other companies joining the Biome network include ConversationHEALTH, which develops AI healthcare chatbots, and Amblyotech, a digital therapeutics company for treating amblyopia.

Novartis announced the news at the virtual XEFFERVESCENCE Digital and AI in the Healthcare Industry event, attended by government officials and members of the healthcare industry.

Canada is investing to position itself as a world-leading destination for AI innovation. In 2017, it was the first country to announce a national AI strategy, and the government has invested $125M in a five-year Pan-Canadian Artificial Intelligence Strategy.

The goals of the strategy include increasing the number of AI researchers and graduates, partnering with AI institutes and developing global thought leadership on the economic, ethical, policy and legal implications of advances in AI.

Christian Macher, country president at Novartis Pharmaceuticals Canada said Novartis was calling on start-ups to join the Biome.

“Our goal with the Biome is to become the leading health tech pharma company in Canada,” he said, “working in collaboration with health tech pioneers who will become our partners in creating better healthcare solutions that can help enhance and accelerate the patient journey from diagnosis through treatment.”

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Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease


  • Health Canada has approved Luxturna (voretigene neparvovec) as a one-time gene therapy for the treatment of adult & pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells
  • Luxturna is designed to provide functioning copies of the RPE65 gene to act in place of mutated RPE65 genes. The functioning genes work to restore vision and improve sight, giving patients the potential for greater independence
  • Novartis has entered a partnership with Blueprint Genetics to facilitate the genetic testing where appropriate to validate the diagnosis

Click here ­to­ read full press release/ article | Ref: Newswire Canada | Image: Technologies

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FDA sets guidelines for drug importation from Canada

Last month, the US Food and Drug Administration published a final rule providing guidance for allowing drug importation from Canada. The drugs have to be approved by the Government of Canada’s Health Canada’s Health Products and Food Branch (HPFB) and can be imported by States or Indian Tribes, or in certain circumstances by pharmacists or wholesale distributors (SIP Sponsors).

The final guidance issued today describes procedures for a drug manufacturer to obtain a National Drug Code (NDC) for certain FDA-approved prescription drugs, including biological products and combination products, that were originally manufactured and intended for sale in that foreign country. The use of an additional NDC for these products may allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require. Prescription drugs, including biological products, imported under the pathway described in the final guidance could be available to patients in a variety of settings, including hospitals, health care providers’ offices or licensed pharmacies, and would include the FDA-approved labeling (including prescribing information)

Note that only prescription drugs with an NDC (i.e., generally, but not exclusively, pills) can be imported but biologic products–such as insulin–are excluded from this provision.

Will this provision help to bring down prices? Perhaps modest, but the Canadian supply is not sufficient to meet US demand. As Kaiser Health News reports:

The Canadian government told HHS [the US Department of Health and Human Services] last spring that the country doesn’t have enough drugs to spare and that the Trump plan would only worsen shortages of medicines there. It argues that Canada’s pharmaceutical market is too small to have any real impact on American prices. Canada represents 2% of the global pharmaceutical consumption, compared to the U.S.’s 44%.

More broadly, the final rule noted that it is impossible to estimate any cost savings since it is unclear which drugs would be planned to be imported.