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In generic rivers and lakes, if Teva is compared to the Dragon Sword of the world, then the Heavenly Sword is none other than Sandoz. Although there is no big brother Teva crowned with that dazzling light, the imitation sharp edge in the hands is equally sharp; “My dad is a Novartis” halo, but the determined Germanic people never slowed down. Through years of unremitting efforts to open up a new world of their own.

Sandoz’s long and rich history of development, bio-similar generics, comprehensive strategic mergers and acquisitions, differentiated products more blooming, like a living history of generic medicine textbooks. The pace has never stopped and the legend is still writing. With the gradual opening of the door to the biosimilar market in the United States, it is believed that Sandoz will continue to write new glorious chapters.

Sandoz: Germanic Eagle soaring

Sandoz is Novartis’s generics business unit, the world’s second-largest generics company, and its global headquarters in Holzkirchen, Germany. With more than 10 large-scale global development centers and 45 production sites, Sandoz has over 160 marketing sites worldwide. The country and the world employ approximately 26,500 people.

Sandoz has more than 120 years of history and currently owns nearly 1100 high-quality pharmaceuticals, covering generic generic drugs and complex high-value-added drugs, benefiting 90% of the world’s population. Sandoz is not only a leader in the field of small molecular generics, but also a pioneer and leader in biopharmaceutical research and development globally. It has strong capabilities in the development and production of biosimilars.

Sandoz’s US company is headquartered in Princeton, New Jersey, with two production sites in Broomfield, Colorado, and East Hanover, New Jersey. It also includes Eon, Oriel Therapeutics, and Fougera’s seven offices in multiple states. Site facilities. The three companies were acquired and merged into Sandoz in 2005, 2010 and 2012 respectively. Sandoz US market products cover cardiovascular, anti-infection, central nervous system, dermatology, digestive system, anti-tumor and immune system, respiratory system and blood system diseases.

Sales performance

Novartis’ 2015 annual report shows that Sandoz’s net sales income was US$9.157 billion, an increase of 7% compared to 2014 (at a constant exchange rate) and accounted for 18% of the Group’s 2015 total sales revenue.

The sales revenue of retail generic drugs, anti-infective and biosimilar drugs/anti-tumor modules were US$7.199 billion, US$5.8 billion and US$1.378 billion, respectively, an increase of 2%, 18% and 39% respectively over the previous year.

From a regional perspective, the United States and Europe are Sandoz’s two largest markets in the world. In addition to the European and American markets, Sandoz has also continued to expand its business in emerging markets such as Asia Pacific and Latin America, achieving varying degrees of growth. US sales increased by 10%, sales in the Asia-Pacific region increased by 13%, sales in Latin America increased by 18%, and Europe increased by 3% (Germany increased by 5%).

According to the IMS Midas database, Sandoz’s sales in the US market in 2015 were US$5.878 billion. A total of 303 molecules and compound combination products were sold in the city (some molecules and compound combinations contain two or more dosage forms, such as ondansetron hydrochloride tablets). And ondansetron hydrochloride injection), of which 285 generic drugs, accounting for nearly 95% of all products, contributed 87% of the total sales.

In terms of dosage forms, it covers tablets, capsules, injections, eye drops, patches, oral liquids, etc. There are more than 20 molecules and compound combinations containing two or more dosage forms, of which the largest proportion is tablets. , More than 40%, followed by injections, capsules, ointments/creams and eye drops, accounting for more than 10%. Sandoz’s sales in the US market for the first half of 2016 were US$2.842 billion; more than 20 products were no longer sold compared to 2015.

In 2015, the listing of Zarxio and Glatopa’s two heavyweight imitation products greatly promoted the growth of sales in the United States market. Zarzio suffered numerous twists and turns due to patent issues in September 2015. In 2015, the cumulative sales volume of each specification exceeded 17,000, and sales revenue was Nearly 6 million US dollars, the sales volume in the first half of 2016 has increased to 135,000, and sales revenue reached US$32 million. Glatopa went public in June 2015, with sales of US$86 million in 2015. Sales reached US$69 million in the first half of 2016, although it still has a long way to go before inciting Teva’s dominance of Copaxone. It is a good thing, after all, the success of the product itself is not small.

Product Strategy

The complex differentiated product strategy is a core part of Sandoz’s global strategy. From the perspective of value, the share of differentiated products has exceeded 1/3 of its entire product portfolio. These high value-added products are mainly targeted at biosimilar drugs, tumor injections, and respiratory drugs, and are three important pillars of their differentiated product strategies.

Biosimilars

In 1980, Sandoz became one of the first manufacturers to produce recombinant protein-interferon.

In 2006, Sandoz introduced the world’s first biomimetic human growth hormone Omnitrope/Somatropin to the EU. With the joint efforts of the regulatory authorities during the review process, Sandoz promoted the establishment of European biosimilar regulations and became one of the early founders. Soon, Omnitrope entered the U.S. market on the NDA route.

In 2007, Sandoz launched the second biosimilar, Binocrit/Epoetinalfa, which was the first biosimilar to enter the European Union for erythropoietin.

In 2009, Sandoz’s third biosimilar, Zarzio/Filgrastim, entered Europe and initially established its leading position in biosimilars.

After years of development, Sandoz has occupied more than half of the global bio-pharmaceutical market share, these three products still maintain a good momentum of growth, as the imitation of swords inlaid with three brilliant gems, become Sandoz Lay the pillar of biological supremacy.

In spite of the promulgation of the new medical reform bill, the door to biosimilar drugs in the US pharmaceutical market is gradually widening. Although it is harder to say than Europe, but better than never, even if the gap is narrow, it is always stronger than it has been. Sandoz once again took the lead. Reasonably and unexpectedly won the first approval (Zarxio) under the 351(K) route. What was even more commendable was the fact that a bloody road was finally achieved and the product was launched in 2015.

But good luck is like a butterfly and will not stay on one’s shoulder forever. In July 2016, PEG-filgrastim, another prokaryotic product declared by Sandoz in the United States, was rejected by the FDA. It undoubtedly poured cold water into the hot state at that time, but this setback is not a big deal for the Sandoz who are in full swing. . The product has also been declared in the European headquarters. It is no small comfort if it can be successfully approved.

In today’s increasingly fierce market competition for biosimilars, several products in the early stage can be used for a while, but they can’t always go to the end. Sandoz is fully aware of the impact and started early on high-end products represented by monoclonal antibodies. The research and development of biosimilars are all under control. The current pipeline includes several hot products of rituximab, adalimumab, infliximab, and etanercept. It plans to complete 11 applications for listing in Europe and the United States by 2017. One has already been completed), and the five European and American markets are expected to be listed on the market by 2020.

In 2016, Erelzi was approved in the United States and became the third 351(K) pathway biosimilar approved by the US FDA. It was also the third biosimilar approved by the United States after Omnitrope and Zarxio in the United States. The development of biosimilar drugs in the market has laid a solid foundation.

Anti-tumor injection

Antitumor injections are another weapon beyond Sandoz’s biosimilar. Tumor injection is a highly specialized product that is difficult to produce because it contains toxins and requires special formulation and handling. After completing the merger and acquisition of EBEWE and successfully integrating, Sandoz became the world’s top generic injection generics and obtained a number of anti-tumor injection products including paclitaxel. The anti-tumor injection product line has been further enriched and enhanced. More than 25 rich product portfolios.

Based on the original EBEWE original site in Unterach, Austria, Sandoz invested a lot of money to further improve it for the development of antitumor injections. The base is equipped with a variety of injection products (including vials, ampoules, and pre-filled syringes) and is equipped with appropriate facilities. At the same time, Sandoz is also actively seeking for the introduction of excellent anti-tumor injections developed and produced by other companies worldwide, further enriching its anti-tumor injection product line, especially for some complex injections that are difficult to develop, such as the use of cyclophosphamide for injections with Hengrui. Amide is one of the representatives.

Inhalers and other differentiated products

In addition to traditional oral solid preparations and injections, Sandoz is also actively developing other differentiated formulations including inhalants, dermatological drugs, patches, and ophthalmic drugs to achieve breakthroughs in these relatively less competitive areas.

Taking the US market as an example, following the acquisition of Fougera, Sandoz’s dermatology medicine field has been greatly enhanced. It has become the world’s number one dermatology generic drug company. Currently, there are nearly 50 dermatological products in the US market and sales in 2015. The accumulative amount has already approached 1 billion US dollars; Ophthalmic drugs have also achieved great development with the help of the close brother Alcon. Currently, it has more than 30 products, and its 2015 sales total has exceeded 500 million US dollars.

Oriel’s incorporation allowed Sandoz to increase its strength in the respiratory field. However, the number of inhalants is still relatively small, but the outlook is consistently positive. The inhaled budesonide suspension marketed in 2015 was sold in the first half of 2016. Revenues have approached 90 million U.S. dollars, and the inhalation of sevoflurane, another product that cooperates with Hengrui, is also full of expectations.

Sandoz’s R&D investment in 2015 was US$776 million, a decrease of 7% from the previous year. Since 2013, Sandoz has started to shut down several R&D centers in the world. While retaining part of the independent research and development of generic drugs, it gradually increases external cooperation and product introduction in order to obtain lower cost and faster speed. Bigger profits.

This product strategy is particularly prominent in the U.S. market. At present, research and development of generic products in the U.S. market has been curtailed. In the future, it will rely more on product introduction to expand its existing product line. It is time for Sandoz U.S. BD bigwigs to come. .

Drug registration

Sandoz launched a total of nine products in the United States in 2015, including four tablets, three injections, patches and inhalants. Three of these products are licensed generics, and metaxalone tablets are marketed again. From the perspective of sales, in the first half of 2016, it exceeded US$1 million, of which six products had sales of more than 10 million, which showed strong potential at the beginning of the listing.

Sandoz’s US-listed New Product Sales in 2015 (2016H1)

Unit: 10,000 U.S. dollars

Sandoz has accumulated more than 300 cumulative ANDA approvals, and it has demonstrated strong strength in patent litigation. The cumulative number of ANDA declarations containing PIV has exceeded 150.

TOP10 products

Sandoz’s TOP10 products are not as heavy as the Teva Copaxone. The performance of the products is relatively balanced and there is no exaggeration. The sales of the top ten products are all over 100 million US dollars.

Three of the 10 products contain more than two dosage forms: clobetasol propionate contains a variety of dosage forms including gels, creams, ointments, and shampoos. Among them, the former three are the series products of their subsidiaries FOUGERA, and the special shampoo formulations are GALDERMA’s authorized generics, produced by the Canadian company G Production Inc.; the combination of amoxicillin and potassium clavulanate also includes oral suspensions. Liquid, normal coated tablets, chewable tablets, and sustained-release tablets are four types of preparations; potassium chloride is included in tablets, capsules, and oral powders. This to a certain extent also reflects Sandoz’s product strategy, through the combination of various formulations to form a group advantage to improve competitiveness.

Seen from the dosage form, it covers tablets, capsules, injections, ophthalmological drugs and topical drugs. Tablets and injections account for the largest proportion; from the therapeutic perspective, they include cardiovascular, anti-infection, gastroenterology, anti-tumor and other major areas. Among them, the proportion of anti-infective drugs is the largest; from the product type, including the authorized introduction of brand drugs, authorized generic drugs and generic generic drugs; from the perspective of manufacturers, their production and external production are basically the same.

Cooperation

Through mergers with companies such as Fougera, Sandoz’s strength in the fields of dermatology and respiratory medicine has grown by leaps and bounds, not to mention the help from the inside. Daddy Novartis used his old baby’s love and authority, and his younger brother, Alcon, can take it. The family’s gifts are also devotional, combined with the country’s past, it’s enough to envy the younger brothers. But if you want to make it bigger, catch up with your brother as soon as possible, just these are still not enough.

Extensive global cooperation is a very important part of Sandoz’s strategy, especially for its core US market. “Made in India” is a very important key word in the global cooperation of the Sandoz US market. Not only has the company cooperated with India’s Gland, Cipal and other companies in product manufacturing, it has also cooperated with many Indian companies such as Mega. The cooperation of APIs has resulted in the purchase of APIs from India for the production of their US market products. In addition, its own factory in India also undertakes the production of a number of pharmaceutical products in the United States market.

However, in recent years, GMP failure has become a major issue that has plagued many Indian companies. Its manufacturing base in India also received a FDA warning letter, which casts a shadow over the future expansion of the Indian market.

Sandoz has three production sites in India: The Turbhe base in Mumbai is the smallest one with more than 170 employees and two production facilities, one for the production of cephalosporins and the other for the pharmaceuticals of Peenan. And the production of sterile injectables; the other two bases are located in Maharashtra, the Mahad base for the manufacture of APIs and the Kalwe base for the production of oral solid preparations. It has more than 1300 employees and is annually produced. Capacity is 180 tons of API and 3 billion tablets of oral formulation. Sandoz has now decided to close its base in Turbhe by the end of 2016. The other two bases will be retained.

As the R&D strategy changes, the introduction of external products that are in line with the company’s strategy as efficiently as possible becomes a very important part of Sandoz. In recent years, the U.S. market has introduced Upsher-Smith’s full range of Klor-Con® (potassium chloride) products, and introduced Anacor’s KERYDINTM® (tavaborole) in the dermatology field. Both products are currently on the Sandoz US market. TOP5, The future sales outlook is very promising. The sales of licensed generic drugs for injection from The Medicines Company, which used biluvadin for injection, also exceeded $80 million in the first half of 2016.

In 2015, Sandoz reached an agreement with BioQ for ready-to-use infusions of ropivacaine and propofol to obtain commercialization rights in the US market. This series of products is pre-filled and dispenses with preparation before use. Compared with the traditional analgesia pump, it is safer, more efficient and lower cost, and it is in line with Sandoz’s differentiated product strategy. In February 2016, Sandoz also entered into a non-exclusive cooperation agreement with MedinCell, an innovative research and development company, to use MedinCell’s BEPO technology platform to jointly develop and commercialize long-acting antitumor injections.

Sandoz ready-to-use ropivacaine and propofol infusion with BioQ

In addition to the US market, China has also become a key implementation area for Sandoz’s US product introduction strategy in recent years. The aforementioned cooperation between Sandoz and Hengrui is one of the classic examples. The two products, ifosfamide for injection and sevoflurane for inhalation, belong to products that have technical barriers and are difficult to imitate. They belong to the field of antitumor injections and respiratory medicines, and are perfect for Sandoz’s differentiated product focus areas. Together. In the US market, ifosfamide for injection is currently only a Baxter competitor. Its sales revenue exceeded 100 million U.S. dollars in 2015 and ranks among the Top 10 products in the Sandoz U.S. market.

The US inhaled competitive landscape with Abbvie, Baxter and Parimal, the traditional top three in the sevoflurane market, has not been broken for many years. It is a challenge but an opportunity for Sandoz. It is natural for both the people and the people to let China and the United States have two exotic brothers come together naturally, and once again shows the importance of “doing well” in the overseas cooperation process of Chinese pharmaceutical companies. Of course, genuine research and development are always Similar basic prerequisites for cooperation. We believe that in the coming days, Sandoz will further expand and deepen its cooperation with China’s outstanding pharmaceutical companies. More “Made in China” will shine in the United States.

development strategy

  • Implementing a “differentiated” product strategy, based on generic generics, it will transfer differential products represented by anti-tumor injections and respiratory products, further improve product lines, consolidate existing areas of excellence, and increase the value-added of products. Big gains.
  • Relying on its own strong litigation capabilities, it actively strives for the first generic listing opportunity through active patent challenge strategies, gains price advantages, enhances the insubstantiality of products through a series of intractable high barrier products, and minimizes market competition.
  • Vigorously develop biosimilar drugs, and based on the original prokaryotic expression products, we have gradually enlarged and strengthened high-end production generic drugs represented by monoclonal antibodies, and gradually expanded to the United States with Europe as the center, in order to become a new business growth point. , maintaining its global dominance of biosimilars.
  • Implement “low-cost” management strategy, reduce some of the production and R & D, and gradually increase the external cooperation and product introduction in the world while relying on the internal resources provided by Novartis, in the brand drugs, authorized generic drugs and generic generic drugs The multi-pronged approach continues to enrich its existing product lines in order to obtain greater profits at a lower cost and at a faster rate.

Future outlook

In recent years, Sandoz’s sales in the US market continued to increase. While the original key products maintained a steady growth, the newly launched products also achieved sales expectations, among which there was no shortage of such glamorous first-generation products, such as Glatopa, with great potential for future growth. The gradual opening of the door for American biosimilars will inevitably bring more room for Sandoz’s future development. With the smooth listing of Zarxio and the successive addition of follow-up monoclonal antibody products, Sandoz believes that it will continue its European glory in the US market and continue. Consolidate its global biosimilar dominance.

Sandoz’s actively implemented differentiated product approach and more efficient cooperation and introduction strategy will also bring considerable economic benefits. Of course, there is never to underestimate the power of affection, and it is not guaranteed that the richest man of the day will make a generous move to collect a few younger brothers.

“Eagle strikes the sky, fish is shallow, and tens of thousands of races are free.” As the wing is fuller, we believe that the German eagle flying on the sky will fly higher and further in the future. Let’s wait and see.

 

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