Europa: Biosimilares $4 billiones en 2017

The European biosimilars market is expected to reach nearly $4 billion by 2017 after the expiration of patents and other intellectual rights opens new opportunities, a new report predicts.

Frost & Sullivan’s Analysis of European Biosimilars Market predicts the industry will record annual growth of more than 50% in the next five years as physicians and patients search for cheaper medication.

Srinivas Sashidhar, a Frost & Sullivan Research Analyst, says the next decade “opens up opportunities for biosimilars to enter the market and increase industry competition”.

The report notes that the biosimilars manufacturing industry is at a nascent stage. The market earned revenue of around $172 million in 2010, research found.

However, while there are plenty of opportunities for growth, the market will require sizeable investment – especially smaller firms. Complex production processes, expensive materials and rigorous clinical trials require significant investment, the report adds.

“The need for considerable financial outlays will hinder the entry of small biotech firms in particular,” warns Mr Sashidhar. “On the other hand, specialty pharmaceutical companies with biotech expertise and financial capabilities are well positioned to venture into the biosimilars market.”

Another obstacle the market faces is high manufacturing costs. But, the report says, viable prospects for licensing agreement between companies should overcome this. “Access to sales and marketing capabilities can be achieved through collaborations between pharmaceutical companies and specialty biotech firms with technical expertise,” said Sashidhar. “Companies can build sales and marketing capabilities in-house and ensure effective marketing support for the commercialisation of biosimilars.”

If the market is to realise its potential in the next decade, the report advises effective sales communication to the scientific community, coupled with continuous promotional activities as well as close and constant interaction with doctors and pharmacists. (Ver)

Ver Biosimilares en PHARMACOSERIAS y Biosimilars

Ver también:

European biosimilar market will be worth $4bn a year by 2017

'Huge' market opportunity for European biosimilars – report/Pharma Times

CPhI 2018 Madrid: Pharma Market Vision /Biosimilar & Generics

Market forecasters remain optimistic about the opportunities for biosimilars and even though the shorter term outlook for generic medicines may be attenuated, the longer term is still positive. 
There are several factors that will influence the final situation.

• _Firstly there needs to be a policy change within the hospital environment to ensure that if a biosimilar wins the contract then there is a procedure in place to ensure that the biosimilar is used in practice. Some countries have introduced quota systems to make sure that biosimilar usage increases and this has worked to a degree. However, the ability of the originator to discount prices does lead to continued use of their products at the expense of the biosimilar. 


• _Further clarification on the right to substitute a biosimilar for the originator product is also required as in practice this does not seem to cause any issues but policies vary on this subject.

Generic medicines will remain under cost pressure and growth will have to be sought in new off-patent opportunities, even though these options may be less fruitful when compared to earlier years. All in all payers need generic medicines and biosimilars, the demand for lower and lower prices should not be allowed to threaten the sustainability of this vital part of the pharmaceutical industry.

Some companies are still hesitant to enter the biosimilar arena but with the advent of biological CDOs/CROs and CMOs there is the opportunity to minimise investments and still become a player. Returns will not be as high as the pure biosimilar play but the ability to have biosimilars within the portfolio will be important for some companies. 
On the generic medicine front the interest in added value generics continues. The major challenge here is obtaining an acceptable price for the medicine. Despite the benefits to patients (and also the cost of non-compliance), payers are reluctant to accept any premium over and above the vanilla generic product. 

Patient groups are on record in stating the issues around polypharmacy and the benefits from something as simple as a fixed dose combination medicine or modified release products. Added value is not just for patients, payers can benefit as well.

I believe that being first to market with a biosimilar will become more important in the future. Therefore a solid development programme and regulatory strategy will be essential. 
Biosimilar use in oncology will increase and open up access to many more patients than previously. Use of biosimilars in diseases of the immune system will drive awareness as their use in high volume primary care indications will position them closely alongside generic medicines. For generic medicines the respiratory device sector is still a challenge but once an acceptable device has been developed then the opportunity is significant.

CPhI Advisory Board member and renowned Pharma Expert, AlanSheppard, Managing Director of Ascher Resources shares insights into the year ahead for generics and biosimilars.
Alan has over 40 years extensive experience within the healthcare industry, including innovator R&D, generic and OTC companies and working with Government, law firms, venture capital companies and industry associations. 
Alan is responsible for developing services provided to the industry and its associations on generic medicines and biosimilars through consulting, information and market analyses.

NOVARTIS: Joe Jimenez no espera que le "copien"...

"Para 2020 se estima 

perderán la patente fármacos biológicos 

por valor de 100.000 millones de dólares, 

lo que nos da una idea 

de la importancia de este mercado" 

Rebecca Guntern / SANDOZ

(Reuters) - Swiss drugmaker Novartis AG does not expect copycat versions of biotech drugs to play an important role in the healthcare system for another three to five years, its chief executive said on Monday. 

Novartis' generics unit Sandoz is the No. 1 player in the field of copycat medicines, known as biosimilars because they are copies of biotech medicines made from living cells that cannot be replicated exactly. 

Chief Executive Joe Jimenez said biosimilars generated about$500 million in sales for Novartis and were growing at a rate of about 20 percent per year. 

"I think in two to three years you're not going to see a big difference," Jimenez told reporters gathered at Novartis' Basel headquarters for an event about the healthcare challenges of an aging population. 

But he said he expected an "inflection point" following big biosimilar launches in 2017, 2018 and 2019, when many high-priced antibody drugs, which are among the pharmaceutical industry's biggest sellers, will lose patent protection. 

Ver

"By the year 2020, which is just five years from now, you're going to see a big impact," Jimenez said. 

Several companies, including include Israel's Teva and Celltrion of South Korea, are racing to develop biosimilars ahead of looming patent expiries on blockbuster biotech medicines for treating cancer and autoimmune diseases. 

As the global population ages, drugmakers such as Novartis are betting on a growing use of biosimilars as cash-strapped healthcare systems look for ways to cut spending. 

 Ver

But uncertainties over the U.S. regulatory framework for biosimilars, plus high manufacturing costs and the need to run clinical trials to win approval, have caused delays. 

Novartis' local rival Roche has repeatedly pushed back forecasts for when its expensive biotech cancer medicines will face generic competition. 

Roche now expects to see biosimilar competition for its blood cancer drug MabThera, which lost patent protection at the end of last year in Europe, from 2016. 

 (Reporting by Caroline Copley; editing by David Clarke)

Ver Biosimilares en PHARMACOSERÍAS

Sandoz y Novartis rompen...

 

Sandoz has completed its separation from Novartis, with the business now continuing as an independent spin-off company.

The separation allows Novartis to fully focus its attention on innovative medicines, the former parent company said, while Sandoz can continue to strengthen its position in generics and biosimilars.

In an announcement, Novartis proposed a stock distribution scheme, offering shareholders one Sandoz share for every five of its own, with all holders set to benefit from “capital and management attention fully focused on innovative medicines”.

Additionally, Novartis said that it “is well-positioned for sustained top- and bottom-line growth”.

Meanwhile, Sandoz has said that it sits in a strong position for “continued profitable growth as a standalone global leader” in generic and biosimilar medicines, following the completion of its first trading day on the SIX Swiss exchange as an independent company.

Sandoz was valued at 10.3bn Swiss francs ($11.2bn), a lower value than previously predicted by analysts of $11bn to $26bn.

Currently, generics and biosimilars account for around 80% of medicines globally, at around 25% of the total cost, with the industry set to grow steadily over the next decade.

Novartis will focus on four core therapeutic areas, cardiovascular, renal and metabolic, immunology, neuroscience and oncology, and will prioritise two established technology platforms, as well as three next-generation platforms to continue its investment in research and development (R&D) capabilities and manufacturing.

Each of these areas will provide the opportunity to address the high disease burden as well as the potential for substantial growth, particularly in the US, China, Germany and Japan.

“Sandoz starts out from a position of strength as a global leader in generics and biosimilars, and I am confident they are poised to deepen their impact on patients and society,” said Narasimhan chief executive officer of Novartis.

He added that Novartis will enter “this new era with strong financial performance and R&D momentum” to “reimagine medicine for and with patients around the globe”.

Chief executive officer of Sandoz, Richard Saynor, commented: “As an independent company, Sandoz will be fully enabled to deliver on its purpose-driven strategy, which targets sustainable leadership in the growing and critical generics and biosimilars industry.”

Ver

THE PIPELINE REPORT 2016 (V): Metabolic

LixiLan (lixisenatide/insulin glargine) Sanofi 

Indication: Type 2 diabetes (Ph.III) 
What the clinical trials found: In a Phase-III trial vs. Sanofi's Lantus, lixisenatide/insulin glargine combination met the primary endpoint of statistically superior reduction in HbA1c (LixiLan-L). The Phase III LixiLan-O trial found the fixed-ratio, once-daily injection of lixisenatide/insulin glargine combination superior to both Lantus (insulin glargine) and Sanofi's Lyxumia (lixisenatide) alone in reducing HbA1c. The combination was well-tolerated with few reported AEs. 
Credit Suisse Success Probability: 50%. Expected launch: 2017 (Source: Credit Suisse) 
Credit Suisse revenue forecast: $975 million in annual global sales by 2020 
What the physicians are saying: Despite new therapy advancements, insulin patients continue to struggle with control. Our data over the past few years have shown an increase in GLP-1 use in combination with insulin, albeit at low levels. Given Lantus's strong standing in the market and the benefits attributable to GLP-1s, physicians will appreciate the convenience of the lixisenatide and Lantus combination. Notably, the addition of a GLP-1 to basal insulin offers the possibility of postprandial control without the risk of weight gain associated with adding a prandial insulin. And, it simplifies the regimen for patients who are already treating several other conditions in addition to diabetes. —Mary McBride, VP, GfK Roper Diabetes 

Semaglutide Novo Nordisk 

Indication: Type 2 diabetes (Ph.III) 
What the clinical trials found: The Phase-III SUSTAIN 3 trial showed that once-weekly injection of 1mg semaglutide provided better glycemic control and greater weight loss than 2mg AstraZeneca's Byetta once-weekly. Semaglutide was generally safe and well tolerated. 
Credit Suisse Success Probability and inThought Comment: 60%. The GLP-1 inhibitors are slowly emerging as having the best efficacy of the pre-insulin diabetes medicines, but there are already similar weekly formulations on the market. Perhaps this one will have a smaller needle or less injection site pain, but more interesting are the various combinations of GLP-1s with insulins or SGLT2 inhibitors. Expected launch: 2017 (Source: Credit Suisse) Credit Suisse revenue forecast: $878 million in annual global sales by 2020 
What the physicians are saying: The GLP-1 market is increasingly crowded, with several once-weekly subcutaneous injection options already on the market. While GLP-1s have been available for more than a decade, uptake has been slow. Where semaglutide will set itself apart is with its oral formulation (O62175C), currently out of Phase II trials. This will appeal to physicians looking to move needle-adverse patients onto a GLP-1. Recent results from SUSTAIN-2 are favorable for semaglutide's subcutaneous formulation, and if the oral formulation performs well on efficacy and safety, physician uptake will follow. —Mary McBride, VP, GfK Roper Diabetes 

MK-1293 (insulin glargine biosimilar) Merck/Samsung Bioepis

Indication: Type 1\2 diabetes (Ph.III) 
What the clinical trials found: In a Phase III study vs. Sanofi's Lantus, the mean change in hemoglobin A1c (A1C) from baseline after 24 weeks is non-inferior in Type 1 diabetes participants treated with MK-1293 (insulin glargine biosimilar). No major safety issues seen. 
inThought Comment: Biosimilar insulins will be an easier sell to doctors than biosimilars for rheumatoid arthritis or cancer. We expect this to be taken up fairly efficiently, and more importantly, for biosimilar insulins to become cornerstones of diabetes franchises. 
What the physicians are saying: Merck and Samsung Bioepis's MK-1293 is one of several insulin glargine biosimilars looking to take share from Lantus. While physicians appreciate the cost savings and expanded insulin options biosimilars will provide, the speed with which physicians are ready to move patients to MK-1293 remains to be seen. Uptake will require strong supporting data and a comfort level that transitioning to a biosimilar will be in the patient's interest. A wait and see attitude will prevail among those requiring reassurance that the differences between MK-1293 and Lantus are not clinically meaningful. Uptake will also be linked to MK-1293's ability to obtain interchangeability status with Lantus at the pharmacy. —Mary McBride, VP, GfK Roper Diabetes

Ver anterior: 
THE PIPELINE REPORT 2016 (IV): Cardiology

ROCHE "derrocha"...predicciones.

Roche CEO Severin Schwann is playing industry oracle and predicting a dramatic path forward for the life sciences industry in Europe. From a news conference held last week, here is what he’s predicting: healthcare spending cuts in Europe, triggered by the debt crisis in Greece will flush out the industry, leaving global generic as well as innovative drug makers among the survivors.

“We will see dramatic changes in the industry,” according to Schwann. “If pressure increases you will have suddenly winners and losers and you have a lot of enterprises that will be squeezed out.”

Survivors would be generic drugmakers with economies of scale needed to handle the volumes of the cheaper copies of branded drugs, as well as drugmakers that find medicines with improved outcomes compared with available drugs. Those in the middle, with little differentiation, would be wiped out. "I’m sure of that”, Schwan said.

Unlike Sanofi Aventis, Merck, Astrazeneca & Novartis, Roche has not (yet) entered biosimilars market. Schwan’s opinion is that biosimilars are less of a threat than pharmaceutical generics because the barriers to entry are much higher, in terms of cost, production and science.

“It’s a different ball game and we expect a much lesser penetration of biosimilars,” Schwan said.

Biosimilares se pueden "merendar" el mercado de insulinas y de ....

Since the launch of the first biosimilar human growth hormone in 2006, biosimilars have become increasingly important to pharmaceutical companies as they try to protect revenue streams from their major brands. Previously, branded biologics were protected from the type of generic erosion that eventually faces all small-molecule therapies by the absence of an abbreviated regulatory pathway for approval of biosimilars. As regulatory agencies have now established, or are in the process of establishing, pathways for approval of biosimilars, companies marketing major biologic brands need to characterize and account for impending competition.

This report forecasts the impending erosion faced by the following biologic drugs used in nephrology and endocrinology:

- Erythropoiesis-stimulating agents (ESAs)—for example, Amgen’s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa); Johnson & Johnson’s Procrit/Eprex (epoetin alfa).

- Insulins and insulin analogues—for example, Eli Lilly’s Humulin (insulin isophane) and Humalog (insulin lispro); Sanofi-Aventis’s Lantus (insulin glargine); NovoNordisk’s Levemir (insulin detemir) and NovoLog/NovoRapid/NovoMix (insulin aspart).

- Human growth hormones (hGHs)/Somatropin—for example, Pfizer’s Genotropin; Eli Lilly’s Humatrope; Novo Nordisk’s Norditropin; Roche’s Nutropin.

Ver...

Que "humorada" Humira llega a Pfizer con "Hospira"...

El 5 de agosto de 2012 John LaMattina comentaba en su columna en Forbes sobre la pobibilidad, no materializada, de que Humira hubiera sido un producto Pfizer y concluia:

"Things can always look better in hindsight, but Humira would have looked pretty good in today’s Pfizer portfolio." (Ver)

Más tarde que nunca lo que pudo haber sido...ahora es:

Pfizer is spending $17 billion to acquire Hospira, which calls itself the world's leading provider of injectable drugs and infusion technologies. 

So what the heck are they? 

Hospira's injectable pharmaceuticals are generic drugs used for anesthesia, infections, cancer and other indications. 

Adalimumab

They differ from what are known as biosimilars—generic versions of biologic drugs, made from living cells (biologic drugs include medicines like Humira, for rheumatoid arthritis, and Avastin, for cancer). While there are biosimilars on the market outside the U.S., the pathway to market is still being worked out here. Hospira makes biosimilars as well.

The company's injectable and infused pharmaceuticals business includes about 200 generic drugs, like the antibacterials azithromycin and ceftazidime, and the anticoagulant heparin sodium. 

"The reason we think it's attractive is simply the technological capability and the experience to be able to develop and manufacture high-quality reliable medicines for a whole range of conditions [including antibiotics to cytotoxic drugs and others] is something really tough to do, and to do well," John Young, head of Pfizer's established products business, said on a conference call with reporters Thursday. Pfizer's existing portfolio of injectables includes the antibiotic Zyvox, chemotherapy docetaxel and birth control shot Depo-Provera. 

Hospira has also been in the news in recent years as the only U.S. maker of drugs used in lethal injection. (The company said in 2011 it would stop making the anesthetic, sodium thiopental, because it didn't have U.S. manufacturing capabilities for it, and it had run into opposition in Italy.) (Más)

Ver también:

Ironias de la muerte... (cont.)

THE PIPELINE REPORT 2016 (III): Autoinmmune

Baricitinib Eli Lilly/Incyte 

Indication: RA (Ph.III) 
What the clinical trials found: The daily oral demonstrated superiority compared to placebo after 12 weeks based on ACR20 response (Ph. III RA-BEAM). The agent also proved superior to adalimumab on key secondary objectives of ACR20 response and improvement in DAS28-hsCRP score. A few occasional AEs were reported. 
Credit Suisse Success Probability and inThought Comment: 70%. The JAK inhibitor appears to have similar efficacy and safety to Pfizer’s Xeljanz. It was supposed to have a once daily vs. Xeljanz’s twice daily advantage, but Xeljanz’s once daily formulation will likely be approved soon. It’ll be interesting to see if Lilly/Incyte can do something with patient access and price to improve upon the poor performance of Xeljanz and expand the JAK inhibitor market. Expected launch: 2016 (Source: Credit Suisse) 
Credit Suisse forecast: $1.09 billion in global annual sales by 2020 
What the physicians are saying: Baricitinib is the most advanced competitor to first-in-class Xeljanz, which caters to patients who have failed anti-TNFs and/or methotrexate; an area where physicians have been awaiting more options. However, price could be a barrier to baricitinib uptake. With the biologic market’s expected growth by 2020, JAK inhibitors have room to develop in a market that seeks effective therapies to improve patient quality of life. —Anita Agier, head of Disease Atlas, GfK Healthcare 

Ozanimod Celgene 

Indication: Relapsing MS/ulcerative colitis (Ph.III) 
What the clinical trials found: Ozanimod in RMS reduced MRI brain lesion activity and met key secondary MRI-based endpoints (RADIANCE, Ph.II). Ozanimod in UC met all efficacy endpoints with statistical significance in patients on the 1mg dose after 32 weeks of treatment (TOUCHSTONE, Ph.II). No severe AEs observed to date. 
Credit Suisse Success Probability and inThought Comment: 25%. The drug looks similar to Gilenya in efficacy and perhaps better in safety. Surprisingly, Novartis never developed Gilenya in ulcerative colitis or Crohn’s disease, so ozanimod has a big advantage and will perhaps become an oral alternative to Humira and Entyvio. Expected launch: 2018 (Source: Credit Suisse) 
Credit Suisse revenue forecast: $900 million in annual global sales by 2020 
What the physicians are saying: Trial findings show ozanimod’s ability to reduce MS relapses and brain lesions. Early opinions indicate a similar safety profile to approved oral agents Tecfidera, Gilenya and Sanofi’s Aubagio, providing another oral option for needle-adverse patients. If results from ongoing Phase III studies show superiority to Biogen’s Avonex and similar or better safety to the current oral therapies, then neurologists could add a formidable weapon to the MS arsenal. —Paul Wojciak, research director, GfK

ABP 501 (adalimumab biosimilar) Amgen 

Indication: RA (Ph.III) 
What the clinical trials found: A Phase III trial in patients with moderate-to-severe RA met its primary endpoint of clinical equivalence between the adalimumab biosimilar and branded adalimumab groups, as measured by ACR20 assessment at week 24. The trial also met its key secondary endpoints, including ACR50, ACR70 and DAS 28-CRP. The safety profile was comparable to adalimumab. 
inThought Comment: There are at least 20 biosimilar adalimumab, etanercept and infliximab agents in global development, but the real question is how this will play out in major markets. We expect the market to support no more than four biosimilar versions of a given drug and believe that deals with payers will dictate winners and losers. 
What the physicians are saying: Despite concerns that these complex substitutes aren’t a perfect replacement, biosimilars will undoubtedly play a leading role in future RA treatment. Most physicians recognize that biosimilars lower costs and give access to a greater number of patients in need of more effective therapies. But a lack of product information and experience will impair their trust. Physician education is one of numerous hurdles the biosimilar will face upon launch as multiple other assets in late phase look to capture a piece of the Humira pie. —Anita Agier, head of Disease Atlas, GfK Healthcare

Ver anterior:
 THE PIPELINE REPORT 2016: Oncology
 

Forbes "Power Women 2018": De 100 solo 2...

.

Solo 2 de 100 (Pharma) mujeres en el Ranking Forbes "Power Woman 2018"

#18 Emma Walmsley   49   U.K

• Walmsley became CEO of GlaxoSmithKline in April of 2017, making her the first (and only) woman to run a major pharmaceutical company.
• Since taking helm of the 300-year-old company, she led a global restructuring program aimed at saving more than $500 million a year by 2021.
• The savings will be invested in R&D spending and funding a pipeline of new products.
• In one of her biggest moves since becoming CEO, Walmsley led this year's $13 billion dollar purchase of Novartis's 36% stake in GSK Consumer Health.
• The deal will allow the drug giant to focus on its three core businesses: pharmaceuticals, vaccines and consumer healthcare.
• In July 2018, she announced a $300 million deal with 23andMe, a San Francisco genetics startup, to develop new medicines.

Ver también: 
Big Pharma’s Latest Breakthrough: Choosing Its First Female Glaxo CEO Emma Walmsley
 

#60 Kiran Mazumdar-Shaw    65    India

· Mazumdar-Shaw, India's richest self-made woman, founded India's largest biopharmaceutical firm in 1978.
· The firm has successfully forayed into the lucrative US biosimilars market, catching the attention of investors and creating a surge in market cap.
· Biocon became the first company to gain approval from the US FDA for two different biosimilars of drugs used in certain cancer treatments.
· She's invested in research infrastructure and scientific talent with the aim of building a deep R&D-based biotech firm, not a copycat generics maker.
· Her philanthropic initiative, The Mazumdar Shaw Medical Centre, aims to create a sustainable, affordable cancer care model.