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Sep
20
Sandeep Singh Dhillon
Malaysia moves forward to combat Hepatitis C; issuing compulsory license to produce generic treatment – MIMS Malaysia
Pharma News, Pharma Notables
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By Reshmin Kaur Cheema

With the rising costs of the Hepatitis C treatment, Malaysian authorities have decided to step up and take measures to ease patients’ burden. They will be following through on plans to allow for generic companies to produce a version of the expensive Sovaldi (Sofosbuvir) pill.

This sets Malaysia as the first country to initiate such move, amidst global headlines highlighting this distressing financial matter. In light of the difficulties governments are facing – especially in Malaysia – patient advocates have commended the move in widening access to treatments.

Putting things into perspective, MIMS previously reported that roughly 500,000 or 2.5% of the Malaysian population are said to be living with chronic liver conditions.

Different approach to tackling increased costs

Executive Director of South Centre, a non-governmental organisation based in Switzerland, Martin Khor wrote to The Star publication stating, “The government decision is the key to opening the door to affordable treatment. The government will have freedom to choose which drug to buy from which firm, at what prices, and with which other drugs to combine it.”

This latest update comes after the government initial plans to issue a supposed government-use license that was announced last month. Following this, Gilead Sciences went on to expand a 2014 licensing deal. This allows for seven larger generic drug makers, with operations in India, to sell copycat forms in middle-income countries like Malaysia, Ukraine, Belarus and Thailand.

The deal was originally thought up to increase access in 101 low-income nations and shut down criticism over the pricey drug status. However, Gilead still endured objections because some of those from middle-income countries cannot afford the Sovaldi drug. Thus, the Malaysian government has decided to roll out generic licensing to bypass the Gilead patent altogether.

Consumer activists say that Malaysia chose to pursue the license as a less restrictive option. They elaborated that Gilead’s ways would jeopardise an ongoing Malaysian project whereby the authorities are working hand in hand with Drugs for Neglected Diseases Initiative – a non-profit and an Egyptian company to produce a generic treatment.

Varying responses – to commend or remain sceptical

Sangeeta Shashikant, a legal advisor to Third World Network (TWN), opined that with this move, Malaysia is projected to obtain combination Hepatitis C treatments for USD300 and perhaps less. The Gilead license, on the other hand, may not reflect the most affordable prices, as pricing relies on the level of generic competition in the country.

Consumers Association of Penang stated that “It is imperative that the government sticks to its decision to issue a government-use license. This is because there are strict limits to what Malaysia can do or cannot import or produce under the Gilead license, and other factors that restrict the freedom to choose the generic companies that it can work with.”

It continued, “…Therefore, it is best for Malaysian consumers and patients that the government have both the government-use license as well as the license scheme that Gilead will extend to Malaysia. Both can co-exist, providing Malaysia with maximum policy choice.”

However, The Galen Centre for Health and Social Policy said Putrajaya should deliberate negotiating the best possible deal with Gilead – including technical support, concessions and additional assistance.

Chief executive Azrul Mohd Khalib said, “This hard-won development would see increased access to a treatment which will improve the quality of life for patients and most importantly, save lives. It represents a moral victory for the government which has worked hard to enhance access for Malaysians to innovative drugs and treatment to treat emerging health challenges.”

However, “implementing a government-use license would be outside that framework. It could represent a pyrrhic approach to a long-term problem with possible consequences and complications,” cautioned Azrul. MIMS

Full article at http://today.mims.com/my-moves-forward-to-combat-hepatitis-c-issuing-compulsory-license-to-produce-generic-treatment?elq_mid=35178&elq_cid=26983

Jun
30
Sandeep Singh Dhillon
FDA list of Drugs without Generic Competition to Prevent Price Gouging – 2017 Business Insider
Pharma News, Pharma Notables
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By Lydia Ramsey

The FDA just took a step that could increase competition and prevent price gouging on drugs that seemingly jump in price overnight.

In May, Food and Drug Administration commissioner Dr. Scott Gottlieb said he wanted to make it more difficult for drugs that are off patent to jack up the price of the medication because they don’t face any competition. The biggest example of this was Daraprim, a decades-old drug that then-Turing CEO Martin Shkreli increased in price from $13.50 to $750 a pill.

To keep that from happening in the future, the FDA on Tuesday published a list of more than 200 drugs that have fallen off patent where the FDA hasn’t received any applications for a generic drug version of that drug.

Before now, it wasn’t too clear which drugs had generic alternatives and which didn’t. That left room for drug companies to buy up those drugs without people noticing and quietly raise their prices. The list could help keep a closer eye on the pool of drugs without generic competition. Ideally, other companies could make generic alternatives to increase competion, lower prices, and keep the drugs from becoming the target of price hikes.

“No patient should be priced out of the medicines they need, we must do our part to help patients get access to the treatments they require,” Gottlieb said in a tweet. “Competition and access are foundational elements to continued pharmaceutical innovation, public health improvement,” he said in a follow-up tweet.

The list includes everything from simple chemical compounds to antibiotics, and glucagon hydrochloride, an emergency diabetes drug that raises the level of blood sugar when it falls too low.

Here is the list

https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/UCM564441.pdf

Jul
21
ragupathyrenganathan
Hospira launches generic bivalirudin for injection in US market
Pharma News
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Jul
2
ragupathyrenganathan
Teva Launches Generic Aggrenox® Capsules in the United States
Pharma News
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Jun
22
sandeepsd
Get information of generic variant of branded drugs in a jiffy
Pharma News
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MANGALURU: The prescription scam unearthed in Delhi a few years back where pharmaceutical companies allegedly paid doctors to prescribe branded drugs vice its generic variant, available at a fraction of the price, started this Bengaluru-based software developer thinking. Read more …

Jun
22
sandeepsd
Sandoz launches Glatopa in US market to treat multiple sclerosis
Pharma News
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Sandoz, a Novartis company, has launched Glatopa in US markets. Glatopa is the first generic version of Teva’s Copaxone (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy. Read more …

Jun
1
ragupathyrenganathan
The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms
Intellectual Property Rights
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May
18
ragupathyrenganathan
Trouble with some generic ADHD drugs – Courtesy (CBS News)
Pharma News
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May
16
ragupathyrenganathan
Glenmark gets tentative USFDA nod for generic psoriasis cream – Courtesy (Business Today)
Pharma News
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May
15
ragupathyrenganathan
Gene Associated with ALS identified ! – Courtesy(Patent Docs)
Intellectual Property Rights, Pharma News
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